Sample records for draft safety evaluation

  1. 78 FR 74151 - Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in... periodic safety reports as described in the guidance entitled ``Periodic Benefit-Risk Evaluation Report... described in the draft guidance entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2...

  2. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ...] Draft Guidance for Industry on ``Target Animal Safety and Effectiveness Protocol Development and...) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of... Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to...

  3. A long-term plan for evaluating the FHWA's Office of Safety programs : final draft

    DOT National Transportation Integrated Search

    2006-01-01

    The purpose of this report is to develop a generalized plan for evaluating and measuring the effectiveness of the major safety programs of the the FHWA Office of Safety. This report is organized into three sections in order to coincide with the state...

  4. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...

  5. 75 FR 6004 - Notice of Intent To Prepare a Draft Environmental Impact Statement and Dam Safety Assurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... evaluation of the main dam's overall earthquake performance. 2. Remediation Alternatives. The draft EIS will address an array of remediation alternatives that are necessary to prevent loss of life, extensive... extent of the remediation alternatives will be determined based on the results of on- going geotechnical...

  6. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.

  7. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...

  8. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...

  9. 49 CFR 229.61 - Draft system.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...

  10. 78 FR 15931 - Sunshine Act Meeting; Request for Comments on Draft Evaluation of Recommended Practice on Fatigue...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Evaluation of Recommended Practice on Fatigue Risk Management Systems for Personnel in the Refining and... and Health Administration: 2001-05-I-DE-1 (Process Safety Management coverage of atmospheric storage tanks); 2005-04-I-TX-9 (Process Safety Management requirement for organizational management of change...

  11. Regulatory assessment with regulatory flexibility analysis : draft regulatory evaluation - Notice of Proposed Rulemaking -- Pipeline Safety : safety standards for increasing the maximum allowable operating pressure for natural gas transmission pipelines.

    DOT National Transportation Integrated Search

    2008-02-01

    The Pipeline and Hazardous Materials Safety Administration (PHMSA) is proposing changes to the Federal pipeline safety regulations in 49 CFR Part 192, which cover the transportation of natural gas by pipeline. Specifically, PHMSA proposes allowing na...

  12. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 7 2011-07-01 2011-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  13. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 7 2014-07-01 2014-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  14. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 7 2012-07-01 2012-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  15. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 7 2013-07-01 2013-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall...

  16. 75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... with the new requirements in the final rule entitled ``Investigational New Drug Safety Reporting...] Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New... the agency considers your comment on this draft guidance before it begins work on the final version of...

  17. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in...

  18. Regulatory assessment with regulatory flexibility analysis and paperwork reduction act analysis : draft regulatory evaluation : Notice of Proposed Rulemaking -- Pipeline Safety : Polyamide-11 (PA-11) plastic pipe design pressures

    DOT National Transportation Integrated Search

    2007-06-01

    The Pipeline and Hazardous Materials Safety Administration (PHMSA) is proposing changes to the Federal pipeline safety regulations in 49 CFR Part 192, which cover the transportation of natural gas by pipeline. Specifically, PHMSA is proposing to chan...

  19. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... document, which addresses safety achieved through drug product design, is the first in a series of planned...] Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors... Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of...

  20. E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice.

    PubMed

    2016-07-19

    The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

  1. 75 FR 20856 - Towing Safety Advisory Committee; Vacancies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... the Coast Guard on matters relating to shallow-draft inland and coastal waterway navigation and towing... advises the Secretary of Homeland Security on matters relating to shallow-draft inland and coastal... with shallow-draft inland and coastal waterway navigation and towing safety. Registered lobbyists are...

  2. 76 FR 3647 - Towing Safety Advisory Committee; Vacancies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... the Coast Guard on matters relating to shallow-draft inland and coastal waterway navigation and towing... Committee advises the Secretary of Homeland Security on matters relating to shallow-draft inland and coastal... operations associated with shallow-draft inland and coastal waterway navigation and towing safety. Registered...

  3. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ....'' This draft guidance describes FDA's current approach to classifying a significant postmarket drug... elevating some priority TSIs to an ``emergency'' status. The draft guidance was developed in connection with... guidance describes CDER's current approach to determining whether a significant postmarket drug safety...

  4. 76 FR 42163 - Pipeline Safety: Issuance of Draft Decision on Det Norske Veritas (USA), Inc.'s Petition for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2011-0075] Pipeline Safety: Issuance of Draft Decision on Det Norske Veritas (USA), Inc.'s...: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice. SUMMARY: This notice...

  5. 77 FR 64836 - Notice of Availability of Draft Environmental Impact Statement (DEIS), Draft Section 4(f...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-23

    ... DEIS for Proposed Runway Safety Area Improvements at the Kodiak Airport, Kodiak, AK AGENCY: Federal... advise the public that a Draft Environmental Impact Statement (DEIS) for proposed Runway Safety Area... the DEIS can be submitted to the individual listed in the section, FOR FURTHER INFORMATION CONTACT. A...

  6. 76 FR 27059 - Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Vaccine...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... Draft Recommendations of the Vaccine Safety Working Group for Consideration by the National Vaccine Advisory Committee on the Federal Vaccine Safety System AGENCY: National Vaccine Program Office, Office of.... ACTION: Notice. SUMMARY: The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply...

  7. Drafting Fundamentals. Drafting Module 1. Instructor's Guide.

    ERIC Educational Resources Information Center

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. The guide contains a cross-reference table of instructional materials. Ten units cover drafting fundamentals: (1) introduction to drafting; (2) general safety;…

  8. 75 FR 6070 - Notice of Public Meeting on the International Atomic Energy Agency Basic Safety Standards Version...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... Energy Agency Basic Safety Standards Version 3.0, Draft Safety Requirements DS379 AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Public Meeting on the International Atomic Energy Agency Basic... development of U.S. Government comments on this International Atomic Energy Agency (IAEA) draft General Safety...

  9. Coosa River Storage Annex, Talladega, Alabama Environmental Investigation, Final Management and Resources Utilization Plan

    DTIC Science & Technology

    1991-02-01

    to adequately assess the health and environmental risks associated with the closure and transfer of the Annex forI other use; and 3) identification of...1990); Draft Final Technical Plan, Draft Final Sampling Design Plan and Draft Final Health and Safety Plan, USATHAMA, June 1990. 2.1.2 Draft Final...Final Technical Plan, Sampling Design Plan and Health and Safety Plan) supplied by USATHAMA. The estimate may be revised, with USATHAMA approval, as

  10. 77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... clinical investigations in determining the amounts and types of safety data to collect in trials conducted... types of safety data that should be collected during late-stage premarket and postmarket clinical...] Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage...

  11. 78 FR 65978 - Draft Revised Strategic Plan for FY 2014-2018

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... DEFENSE NUCLEAR FACILITIES SAFETY BOARD Draft Revised Strategic Plan for FY 2014-2018 AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Notice. SUMMARY: In accordance with Office of Management and Budget Circular No. A-11, the Defense Nuclear Facilities Safety Board (DNFSB) is soliciting...

  12. 75 FR 4794 - Draft Revised Strategic Plan for FY 2010-2015

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-29

    ... DEFENSE NUCLEAR FACILITIES SAFETY BOARD Draft Revised Strategic Plan for FY 2010-2015 AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Notice. SUMMARY: In accordance with OMB Circular No. A-11, the Defense Nuclear Facilities Safety Board is soliciting comments from all interested and potentially...

  13. Fire Safety Tests for Cesium-Loaded Spherical Resorcinol Formaldehyde Resin: Data Summary Report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kim, Dong-Sang; Schweiger, Michael J.; Peterson, Reid A.

    2012-09-01

    A draft safety evaluation of the scenario for spherical resorcinol formaldehyde (SRF) resin fire inside the ion exchange column was performed by the Hanford Tank Waste Treatment and Immobilization Plant (WTP) Fire Safety organization. The result of this draft evaluation suggested a potential change of the fire safety classification for the Cesium Ion Exchange Process System (CXP) emergency elution vessels, equipment, and piping. To resolve this question, the fire properties of the SRF resin were measured by Southwest Research Institute (SwRI) through a subcontract managed by Pacific Northwest National Laboratory (PNNL). The results of initial fire safety tests on themore » SRF resin were documented in a previous report (WTP-RPT-218). The present report summarizes the results of additional tests performed by SwRI on the cesium-loaded SRF resin. The efforts by PNNL were limited to summarizing the test results provided by SwRI into one consolidated data report. The as-received SwRI report is attached to this report in the Appendix A. Where applicable, the precision and bias of each test method, as given by each American Society for Testing and Materials (ASTM) standard procedure, are included and compared with the SwRI test results of the cesium-loaded SRF resin.« less

  14. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... container labels and carton labeling design, is the second in a series of three planned guidance documents...] Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To... entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

  15. A Legislative Reform for the Food Safety System of China: A Regulatory Paradigm Shift and Collaborative Governance.

    PubMed

    Han, Yonghong

    2015-01-01

    After describing the historical development of China's food safety system from the perspectives of legislation and administration, this article discusses progress in its food law (The Draft Amendments to Food Safety Law). As a further legislative reform for China's food safety system, the Draft Amendments to the Food Safety Law contain innovative institutional designs and manifest a regulatory paradigm shift from government-centered governance to collaborative governance. However, the Draft Amendments face challenges in their implementation. This article argues that developing collaborative governance for food safety in China can be a solution to these challenges. Based on theoretical and empirical studies of collaborative governance, this article proposes that the institutional design of collaborative governance should focus on providing obligations for administrative agencies in the process of food safety rule-making and standard-setting, increasing the independence of nongovernmental organizations, and building two-way electronic platforms for public participation.

  16. 75 FR 1831 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on AP1000...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ...-3, 2010, 11545 Rockville Pike, Room T2-B1, Rockville, Maryland. The meeting will be open to public... the Draft Safety Evaluation Report associated with the amendment to the Westinghouse AP1000 Design...

  17. ESA Human rating Requirements:Status

    NASA Astrophysics Data System (ADS)

    Trujillo, M.; Sgobba, T.

    2012-01-01

    The European Space Agency (ESA) human rating safety requirements are based on heritage requirements of the International Space Station as well as the knowledge and experience derived from European participation on international partnerships. This expertise in conjunction with recommendations derived from past accidents (i.e.: Columbia) and lessons learned have led to the identification of m inimum core safety tech nical requirements for hum an rated space syst ems. These requirements apply to th e crewed space vehicle, integrated space system (i.e.: cre wed vehicle on its launcher) and its interfaces with control centres, la unch pad, etc. In 2009, a first draft was issued. Then, in the summer of 2010, ESA established a working group comprised of more than twenty experts (from disciplines including propulsion, pyrotechnics, structures, avionics, human factors and life support among others) across the Agency to review this draft. This paper provides an overview of ESA "Safety technical re quirements for human rated s pace systems" document, its scope a nd structure, as well as the planned steps for verification of these requirements in term s of achieving the identified safety objectives for crew safety in t erms of a quantitative risk evaluation.

  18. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  19. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  20. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  1. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  2. 49 CFR 215.127 - Defective draft arrangement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.127 Defective draft arrangement. A railroad may not place or continue in service a car, if— (a) The car has a draft gear that is inoperative; (b) The car has a broken yoke; (c) An end of car...

  3. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 7 2010-07-01 2010-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations...) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall be built or means shall be taken to prevent cargo from falling from them. (b) Buckets and tubs used...

  4. Environmental Assessment for Construction of Radial Arm Spill Gates MacDill Air Force Base, Florida

    DTIC Science & Technology

    2012-05-01

    requires that Federal agencies identify and assess environmental health and safety risks that might disproportionately affect children. The Proposed...Action would not pose any adverse or disproportionate environmental health or safety risks to children living near the base. Safety precautions...Department of Envir. Protection 3900 Commonwealth Blvd, Mail Station 47 Tallahassee, FL 32399-3000 RE: Draft Environmental Assessment and Draft

  5. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  6. 78 FR 9702 - Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, and... evaluate and mitigate immune responses that may adversely affect their safety and efficacy. DATES: Although... these factors that may reduce the likelihood that these products will generate an immune response. In...

  7. Fire Safety Tests for Spherical Resorcinol Formaldehyde Resin: Data Summary Report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kim, Dong-Sang; Peterson, Reid A.; Schweiger, Michael J.

    2012-07-30

    A draft safety evaluation of the scenario for spherical resorcinol-formaldehyde (SRF) resin fire inside the ion exchange column was performed by the Hanford Tank Waste Treatment and Immobilization Plant (WTP) Fire Safety organization. The result of this draft evaluation suggested a potential change of the fire safety classification for the Cesium Ion Exchange Process System (CXP) emergency elution vessels, equipment, and piping, which may be overly bounding based on the fire performance data from the manufacturer of the ion exchange resin selected for use at the WTP. To resolve this question, the fire properties of the SRF resin were measuredmore » by Southwest Research Institute (SwRI), following the American Society for Testing and Materials (ASTM) standard procedures, through a subcontract managed by Pacific Northwest National Laboratory (PNNL). For some tests, the ASTM standard procedures were not entirely appropriate or practical for the SRF resin material, so the procedures were modified and deviations from the ASTM standard procedures were noted. This report summarizes the results of fire safety tests performed and reported by SwRI. The efforts by PNNL were limited to summarizing the test results provided by SwRI into one consolidated data report. All as-received SwRI reports are attached to this report in the Appendix. Where applicable, the precision and bias of each test method, as given by each ASTM standard procedure, are included and compared with the SwRI test results of the SRF resin.« less

  8. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  9. 76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... holders, and other stakeholders on a draft guidance document entitled ``Weapons Safety Assessment'' (WSA... weapons under the NRC's proposed rule titled ``Enhanced Weapons, Firearms Background Checks, and Security.... You should not include any site-specific security information in your comments. Federal rulemaking Web...

  10. 78 FR 49543 - Towing Safety Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... 4 through 6, 2013, in Chicago, Illinois to discuss issues related to shallow draft inland, coastal... Commandant for Operations on matters relating to shallow-draft inland and coastal waterway navigation and... independent judgment to the Secretary on matters and actions concerning shallow-draft inland and coastal...

  11. 77 FR 28600 - Draft publication: Coal Dust Explosibility Meter Evaluation and Recommendations for Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number... Recommendations for Application Authority: 30 U.S.C. 95l. AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human...

  12. Evaluation of an Alcohol-Based Sanitizer Spray's Bactericidal Effects on Salmonella Inoculated onto Stainless Steel and Shell Egg Processing Equipment

    USDA-ARS?s Scientific Manuscript database

    Introduction: Safety regulations are being drafted for the shell egg industry. Sanitation standard operating procedures are an important precursor to HACCP regulations. Salmonella is the pathogen was most often associated with egg-borne outbreaks. Developing effective sanitation procedures that wil...

  13. Materials and Manufacturing, Drafting 3: 9257.03.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Designed for students interested in engineering fields pertaining to mechanical and electronic drafting, the course covers several types of drawings in the mechanical and electronic drafting field and many types of machine shop operations. The student will become familiar with stress, loading, safety factors, and manufacturing processes. The…

  14. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...

  15. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final... products, FDA headquarters and field personnel, and the public of CDRH's proposed approach on the safety of... limits. While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children's toy...

  16. Drafting. A Bilingual Text = Dibujo Mecanico. Un Texto Bilingue.

    ERIC Educational Resources Information Center

    Los Angeles Unified School District, CA. Div. of Career and Continuing Education.

    This bilingual instructional text, one in a series of six texts covering various vocational and technical topics, provides secondary level English and Spanish instruction in drafting. Addressed in the individual units are the following topics: safety, drafting tools and techniques, sketching, geometric construction, working drawings, sectioning,…

  17. Basic Drafting: Book One.

    ERIC Educational Resources Information Center

    Davis, Ronald; And Others

    The first of a two-book course in drafting, this manual consists of 13 topics in the following units: introduction to drafting, general safety, basic tools and lines, major equipment, applying for a job, media, lettering, reproduction, drawing sheet layout, architect's scale usage, civil engineer's scale usage, mechanical engineer's scale usage,…

  18. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... the availability of a draft guidance for industry entitled ``Certification Process for Designated Medical Gases.'' This draft guidance describes the new certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to...

  19. 78 FR 78063 - Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ...ScienceResearch/UCM334110.pdf . 2. FDA, ``Appendix 4 to Draft Qualitative Risk Assessment of Risk of....regulations.gov and at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM377408... on a Farm,'' 2013. Available at: http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafety...

  20. 76 FR 30280 - Public Meeting To Discuss the Proposed Rule on Enhanced Weapons, Firearms Background Checks, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... Proposed Rule on Enhanced Weapons, Firearms Background Checks, and Security Event Notifications AGENCY... the proposed enhanced weapons rule, the two draft regulatory guides, and the draft weapons safety.... No formal comments on the proposed enhanced weapons rule or the draft guidance documents will be...

  1. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ...] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters... a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondence...

  2. 77 FR 67678 - Content Specifications and Shielding Evaluations for Type B Transportation Packages

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-13

    ...The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2012-XX, ``Content Specifications and Shielding Evaluations for Type B Transportation Packages.'' This RIS clarifies the NRC's use of staff guidance in NUREG-1609, ``Standard Review Plan for Transport Packages for Radioactive Material,'' for the review of content specifications and shielding evaluations included in the Certificates of Compliance (CoC) and safety analysis reports (SARs) for Type B transportation packages.

  3. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

  4. Premise to Implement a Grading System to Evaluate the Sanitary Level in Food Service Establishments in Milan, Italy

    PubMed Central

    Razzini, Katia

    2015-01-01

    The regulatory framework of the official controls on food safety, the criteria and methods from the planning of interventions in the field of official control to the management of information flows, and the standards described in the operation manual of the local competent authorities drafted by the Lombardy Region (2011) were evaluated. A questionnaire consisting of n. 10 questions with multiple answers draft in partnership with EPAM (the Association of Provincial Public Retail and catering businesses in Milan) to n. 107 Food service establishments of Milan shows that 92% of managers approve the introduction of a grading system. The regulatory framework is planned to support the implementation of risk assignment, unfortunately the attribution of risk category of retail and catering businesses is still different among regions. PMID:27800403

  5. EPA Extends Comment Period for Draft Label Revisions on Respirators

    EPA Pesticide Factsheets

    Extending Comment Period for Draft Label Revisions on Respirators, Bring the respirator descriptions on pesticide labels into conformance with the current National Institute for Occupational Safety and Health (NIOSH) respirator language

  6. Measure Guideline: Combustion Safety for Natural Draft Appliances Through Appliance Zone Isolation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Fitzgerald, J.; Bohac, D.

    2014-04-01

    This measure guideline covers how to assess and carry out the isolation of natural draft combustion appliances from the conditioned space of low-rise residential buildings. It deals with combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage. This subset of houses does not require comprehensive combustion safety tests and simplified prescriptive procedures can be used to address safety concerns. This allows residential energy retrofit contractors inexperienced in advanced combustion safety testing to effectively address combustion safety issues and allow energy retrofitsmore » including tightening and changes to distribution and ventilation systems to proceed.« less

  7. Evaluation of a low-temperature steam and formaldehyde sterilizer.

    PubMed

    Kanemitsu, K; Kunishima, H; Imasaka, T; Ishikawa, S; Harigae, H; Yamato, S; Hirayama, Y; Kaku, M

    2003-09-01

    We evaluated a low-temperature steam and formaldehyde (LTSF) sterilizer based on the draft European Standard prEN 14180. Microbiological tests were conducted on small and full loads using process challenge devices in five programs (P1-P5). With small loads all tests showed no growth of Bacillus stearothermophilus (ATCC7953) spores. However, positive cultures were observed with full-load tests using P5 (sterilization temperature, 50 degrees C). Our data indicated that the load influenced the efficacy of the LTSF sterilizer. Desorption tests were conducted to determine residual formaldehyde in indicator strips. The mean concentrations of formaldehyde in P1-P5 were 31.9, 56.3, 54.9, 82.2 and 180.6 microg, respectively, which are below the limits allowed by the draft Standard. Our results indicate that the LTSF sterilizer is useful for sterilization because of its excellent efficacy, short handling time, and safety.

  8. 75 FR 75707 - Request for Public Comment on the Draft National Nanotechnology Initiative Strategy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... Nanotechnology Initiative Strategy for Nanotechnology-Related Environmental, Health, and Safety Research AGENCY... the public regarding the draft National Nanotechnology Initiative (NNI) Strategy for Nanotechnology... confidential. Overview: The National Nanotechnology Initiative Strategy for Nanotechnology-Related...

  9. 76 FR 2428 - Request for Public Comment on the Draft National Nanotechnology Initiative Strategy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... Nanotechnology Initiative Strategy for Nanotechnology-Related Environmental, Health, and Safety Research AGENCY... the public regarding the draft National Nanotechnology Initiative (NNI) Strategy for Nanotechnology... considered proprietary, personal, sensitive, or confidential. Overview: The National Nanotechnology...

  10. A systems-based food safety evaluation: an experimental approach.

    PubMed

    Higgins, Charles L; Hartfield, Barry S

    2004-11-01

    Food establishments are complex systems with inputs, subsystems, underlying forces that affect the system, outputs, and feedback. Building on past exploration of the hazard analysis critical control point concept and Ludwig von Bertalanffy General Systems Theory, the National Park Service (NPS) is attempting to translate these ideas into a realistic field assessment of food service establishments and to use information gathered by these methods in efforts to improve food safety. Over the course of the last two years, an experimental systems-based methodology has been drafted, developed, and tested by the NPS Public Health Program. This methodology is described in this paper.

  11. 77 FR 75443 - Draft Safety Culture Policy Statement: Request for Public Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... personal and organizational characteristics are present in a positive safety culture. A characteristic, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal...

  12. 77 FR 31631 - Towing Safety Advisory Committee; Vacancies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... the Secretary of Homeland Security on matters relating to shallow-draft inland and coastal waterway.... 111-281). The Committee advises the Secretary of Homeland Security on matters relating to shallow... towing industry, marine transportation, or business operations associated with shallow-draft inland and...

  13. Drafting Lab Management Guide.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. Instructional Materials Lab.

    This manual was developed to guide drafting instructors and vocational supervisors in sequencing laboratory instruction and controlling the flow of work for a 2-year machine trades training program. The first part of the guide provides information on program management (program description, safety concerns, academic issues, implementation…

  14. 75 FR 57081 - Revised Draft Safety Culture Policy Statement: Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

    ... on Safety Culture at the Health Physics Society Annual Meeting, and presentations on the development... holders \\2\\ establish and maintain a positive safety culture that protects public health and safety and... public health and safety, the Commission has required the regulated entity involved to determine the...

  15. Draft environmental impact statement : corporate average fuel economy standards, passenger cars and light trucks, model years 2011-2015.

    DOT National Transportation Integrated Search

    2008-06-01

    The National Highway Traffic Safety Administration (NHTSA) has prepared this Draft Environmental Impact Statement (DEIS) to disclose and analyze the potential environmental impacts of the proposed new Corporate Average Fuel Economy (CAFE) standards a...

  16. 10 CFR 1.23 - Office of the General Counsel.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., providing opinions, advice, and assistance to the agency with respect to all of its activities; (b) Reviews and prepares appropriate draft Commission decisions on public petitions seeking direct Commission... and reviews draft Commission decisions on Atomic Safety and Licensing Board decisions and rulings; (c...

  17. The National Football League Combine: performance differences between drafted and nondrafted players entering the 2004 and 2005 drafts.

    PubMed

    Sierer, S Patrick; Battaglini, Claudio L; Mihalik, Jason P; Shields, Edgar W; Tomasini, Nathan T

    2008-01-01

    The purpose of this study was to examine performance differences between drafted and nondrafted athletes (N = 321) during the 2004 and 2005 National Football League (NFL) Combines. We categorized players into one of 3 groups: Skill, Big skill, and Linemen. Skill players (SP) consisted of wide receivers, cornerbacks, free safeties, strong safeties, and running backs. Big skill players (BSP) included fullbacks, linebackers, tight ends, and defensive ends. Linemen (LM) consisted of centers, offensive guards, offensive tackles, and defensive tackles. We analyzed player height and mass, as well as performance on the following combine drills: 40-yard dash, 225-lb bench press test, vertical jump, broad jump, pro-agility shuttle, and the 3-cone drill. Student t-tests compared performance on each of these measures between drafted and nondrafted players. Statistical significance was found between drafted and nondrafted SP for the 40-yard dash (P < 0.001), vertical jump (P = 0.003), pro-agility shuttle (P < 0.001), and 3-cone drill (P < 0.001). Drafted and nondrafted BSP performed differently on the 40-yard dash (P = 0.002) and 3-cone drill (P = 0.005). Finally, drafted LM performed significantly better than nondrafted LM on the 40-yard dash (P = 0.016), 225-lb bench press (P = 0.003), and 3-cone drill (P = 0.005). Certified strength and conditioning specialists will be able to utilize the significant findings to help better prepare athletes as they ready themselves for the NFL Combine.

  18. 77 FR 73114 - Draft Written Re-Evaluation for Environmental Impact Statement: T.F. Green Airport, Warwick, RI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    [email protected]gov Include ``Comment to T.F. Green Draft Written Re-Evaluation'' in the subject line Mail... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Draft Written Re-Evaluation for... notice to advise the public that a Draft Written Re-Evaluation for an Environmental Impact Statement (EIS...

  19. 75 FR 50774 - Towing Safety Advisory Committee; Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... will meet in Pittsburgh, PA. The Committee will also discuss various issues relating to shallow-draft... Secretary of the Department of Homeland Security (DHS) on matters relating to shallow-draft inland and... reflecting the Committee's independent judgment to the Secretary on matters and actions concerning shallow...

  20. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Substances, Including Food Ingredients That Are Color Additives; Availability AGENCY: Food and Drug... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food...

  1. Mechanical Drafting Curriculum Guide. Michigan Trade and Industrial Education.

    ERIC Educational Resources Information Center

    Michigan State Univ., East Lansing. Coll. of Agriculture and Natural Resources Education Inst.

    This task-based curriculum guide is intended to help secondary teachers provide relevant training for an entry-level job in mechanical drafting. Introductory materials include background information on trade and industrial education and program goals and safety information. Descriptions follow of the construction trades program, vocational…

  2. Safety in Outdoor Adventure Programs. S.O.A.P. Safety Policy.

    ERIC Educational Resources Information Center

    MacDonald, Wayne, Comp.; And Others

    Drafted in 1978 as a working document for Safety in Outdoor Adventure Programs (S.O.A.P.) by a council of outdoor adventure programmers, checklists outline standard accepted safety policy for Outdoor Adventure Programs and Wilderness Adventure Programs conducted through public or private agencies in California. Safety policy emphasizes: the…

  3. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

  4. Draft Genome Sequence of Bifidobacterium animalis subsp. lactis Strain CECT 8145, Able To Improve Metabolic Syndrome In Vivo.

    PubMed

    Chenoll, E; Codoñer, F M; Silva, A; Martinez-Blanch, J F; Martorell, P; Ramón, D; Genovés, S

    2014-03-27

    Bifidobacterium animalis subsp. lactis strain CECT 8145 is able to reduce body fat content and improve metabolic syndrome biomarkers. Here, we report the draft genome sequence of this strain, which may provide insights into its safety status and functional role.

  5. 9 CFR 439.5 - Applications for accreditation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 439.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., for each accreditation sought, submit a check, bank draft, or money order in the amount specified in 9... are payable upon receipt by check, bank draft, or money order made payable to the U.S. Department of...

  6. Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs) . Volume 2; Appendices

    NASA Technical Reports Server (NTRS)

    Prosser, William H.

    2014-01-01

    In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This document contains the appendices to the main report.

  7. Proposed Performance Measures and Strategies for Implementation of the Fatigue Risk Management Guidelines for Emergency Medical Services.

    PubMed

    Martin-Gill, Christian; Higgins, J Stephen; Van Dongen, Hans P A; Buysse, Daniel J; Thackery, Ronald W; Kupas, Douglas F; Becker, David S; Dean, Bradley E; Lindbeck, George H; Guyette, Francis X; Penner, Josef H; Violanti, John M; Lang, Eddy S; Patterson, P Daniel

    2018-02-15

    Performance measures are a key component of implementation, dissemination, and evaluation of evidence-based guidelines (EBGs). We developed performance measures for Emergency Medical Services (EMS) stakeholders to enable the implementation of guidelines for fatigue risk management in the EMS setting. Panelists associated with the Fatigue in EMS Project, which was supported by the National Highway Traffic Safety Administration (NHTSA), used an iterative process to develop a draft set of performance measures linked to 5 recommendations for fatigue risk management in EMS. We used a cross-sectional survey design and the Content Validity Index (CVI) to quantify agreement among panelists on the wording and content of draft measures. An anonymous web-based tool was used to solicit the panelists' perceptions of clarity and relevance of draft measures. Panelists rated the clarity and relevance separately for each draft measure on a 4-point scale. CVI scores ≥0.78 for clarity and relevance were specified a priori to signify agreement and completion of measurement development. Panelists judged 5 performance measures for fatigue risk management as clear and relevant. These measures address use of fatigue and/or sleepiness survey instruments, optimal duration of shifts, access to caffeine as a fatigue countermeasure, use of napping during shift work, and the delivery of education and training on fatigue risk management for EMS personnel. Panelists complemented performance measures with suggestions for implementation by EMS agencies. Performance measures for fatigue risk management in the EMS setting will facilitate the implementation and evaluation of the EBG for Fatigue in EMS.

  8. Road safety measures : a catalogue of estimates of effect : summary

    DOT National Transportation Integrated Search

    2002-04-01

    This report contains a catalogue of estimates of the effects on road safety of selected road safety measures. The report is intended to be used as a reference manual in drafting the national transport plan for Norway for the term 2006-2015.

  9. 77 FR 45417 - Notice of Availability of Draft Environmental Assessment for Public Comment for the Longhorn...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID... Longhorn Pipeline Reversal Project AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA... Parts 1500-1508, the Pipeline and Hazardous Materials Safety Administration (PHMSA) is announcing the...

  10. Draft Genome Sequences of 37 Salmonella enterica Strains Isolated from Poultry Sources in Nigeria

    PubMed Central

    Useh, Nicodemus M.; Ngbede, Emmanuel O.; Akange, Nguavese; Thomas, Milton; Foley, Andrew; Keena, Mitchel Chan; Nelson, Eric; Christopher-Hennings, Jane; Tomita, Masaru

    2016-01-01

    Here, we report the availability of draft genomes of several Salmonella serotypes, isolated from poultry sources from Nigeria. These genomes will help to further understand the biological diversity of S. enterica and will serve as references in microbial trace-back studies to improve food safety. PMID:27151793

  11. Draft Genome Sequence of Bacillus coagulans GBI-30, 6086, a Widely Used Spore-Forming Probiotic Strain

    PubMed Central

    Orrù, Luigi; Salvetti, Elisa; Cattivelli, Luigi; Lamontanara, Antonella; Michelotti, Vania; Capozzi, Vittorio; Spano, Giuseppe; Keller, David; Cash, Howard; Martina, Alessia; Felis, Giovanna E.

    2014-01-01

    Bacillus coagulans GBI-30, 6086 is a safe strain, already available on the market, and characterized by certified beneficial effects. The draft genome sequence presented here constitutes the first pillar toward the identification of the molecular mechanisms responsible for its positive features and safety. PMID:25377698

  12. 78 FR 11204 - Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ...] Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance... announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for... Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA...

  13. Draft genomic sequencing of six potential extraintestinal pathogenic Escherichia coli isolates from retail chicken meat.

    USDA-ARS?s Scientific Manuscript database

    Potential Extraintestinal pathogenic Escherichia coli isolates DP254, WH333, WH398, F356, FEX675 and FEX725 were isolated from retail chicken meat products. Here, we report the draft genome sequences for these six E. coli isolates, which are currently being used in food safety research....

  14. 78 FR 42387 - Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C...

  15. 75 FR 22758 - Notice of Intent To Prepare a Draft Environmental Impact Statement and Dam Safety Assurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... instrumentation to ensure adequate monitoring and to provide suitable baseline information. 2. Remediation Alternatives. The draft EIS will address an array of remediation alternatives that are necessary to prevent... benefits. The exact nature and extent of the remediation alternatives will be determined based on the...

  16. 75 FR 1656 - Draft Safety Culture Policy Statement: Request for Public Comments; Extension of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-12

    ... unique aspects of nuclear safety and security, and to note the Commission's expectations that all NRC... health and safety and the common defense and security when carrying out licensed activities. The comment...) development of high-level [[Page 1657

  17. Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs.

    PubMed

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M Stacey; McGuinn, W David; Verbois, S Leigh

    2010-03-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

  18. Draft Genome Sequences of 37 Salmonella enterica Strains Isolated from Poultry Sources in Nigeria.

    PubMed

    Useh, Nicodemus M; Ngbede, Emmanuel O; Akange, Nguavese; Thomas, Milton; Foley, Andrew; Keena, Mitchel Chan; Nelson, Eric; Christopher-Hennings, Jane; Tomita, Masaru; Suzuki, Haruo; Scaria, Joy

    2016-05-05

    Here, we report the availability of draft genomes of several Salmonella serotypes, isolated from poultry sources from Nigeria. These genomes will help to further understand the biological diversity of S. enterica and will serve as references in microbial trace-back studies to improve food safety. Copyright © 2016 Useh et al.

  19. Draft genome sequences of four uropathogenic escherichia coli 04:H5 isolates (ATCC 700414,700415,700416 and 700417)

    USDA-ARS?s Scientific Manuscript database

    Uropathogenic Escherichia coli O4: H5 isolates ATCC 700414, 700415, 700416, and 700417 were recovered from women with first-time urinary tract infections. Here, we report the draft genome sequences for these four E. coli isolates, which are currently being used to validate food safety processing tec...

  20. Draft Genomic Sequencing of Six Potential Extraintestinal Pathogenic Escherichia coli Isolates from Retail Chicken Meat

    PubMed Central

    Xu, Aixia; Johnson, James R.; Sheen, Shiowshuh; Needleman, David S.

    2018-01-01

    ABSTRACT Potential extraintestinal pathogenic Escherichia coli strains DP254, WH333, WH398, F356, FEX675, and FEX725 were isolated from retail chicken meat products. Here, we report the draft genome sequences for these six E. coli isolates, which are currently being used in food safety research. PMID:29798928

  1. 75 FR 57104 - Pipeline Safety: Request for Special Permit and Availability of Draft Environmental Assessment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

    ... Docket No. PHMSA-2008-0257. We invite the public and all concerned to review these documents and provide... of Draft Environmental Assessment. SUMMARY: PHMSA is providing an additional public comment period... an opportunity for public comment on April 23, 2009 (74 FR 4296). PHMSA is also providing notice of...

  2. 78 FR 76288 - Notice of Intent To Prepare a Draft Environmental Impact Statement and Dam Safety Modification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... Aurora, Colorado (southeast Denver metropolitan area). The remediation actions will be identified through... options may include federal actions which will be the subject of the EIS. 2. Remediation Alternatives. The draft EIS will address an array of remediation alternatives that could reduce the risk of life loss...

  3. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (2011 Interagency Science Discussion Draft)

    EPA Science Inventory

    On September 22, 2006, the draft Evaluation of the Carinogenicity of Ethylene Oxide (EPA/635/R-06/003) and the draft charge to external peer reviewers were released for external peer review and public comment. This draft was reviewed by EPA’s Science Advisory Board (SAB)...

  4. Safety and fitness electronic records (SAFER) system : logical architecture document : working draft

    DOT National Transportation Integrated Search

    1997-01-31

    This Logical Architecture Document includes the products developed during the functional analysis of the Safety and Fitness Electronic Records (SAFER) System. This document, along with the companion Operational Concept and Physical Architecture Docum...

  5. Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs)

    NASA Technical Reports Server (NTRS)

    Prosser, William H.

    2014-01-01

    In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This report contains the outcome of the assessment and the findings, observations, and NESC recommendations to the Agency and individual NASA Centers.

  6. Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs). Corrected Copy, Aug. 25, 2014

    NASA Technical Reports Server (NTRS)

    Prosser, William H.

    2014-01-01

    In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This report contains the outcome of the assessment and the findings, observations, and NESC recommendations to the Agency and individual NASA Centers.

  7. 76 FR 13605 - Notice of Availability of Draft Waste Incidental to Reprocessing Evaluation for the Vitrification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... DEPARTMENT OF ENERGY Notice of Availability of Draft Waste Incidental to Reprocessing Evaluation...: Office of Environmental Management, U.S. Department of Energy. ACTION: Notice of availability. SUMMARY: The Department of Energy (DOE) announces the availability of a draft evaluation which shows that the...

  8. 78 FR 48696 - Draft Revisions to the Marine Safety Manual, Volume III, Chapters 20-26

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ...) Updated provisions for vessel manning, including guidance for the issuing of safe manning documents; (2... Distress and Safety System (GMDSS), and the Principles of Minimum Safe Manning (IMO Resolution A.1047(27...

  9. 76 FR 69294 - Proposed Generic Communication Draft Generic Letter on Seismic Risk Evaluations for Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    .... Nuclear Regulatory Commission (NRC) published for public comment Draft Generic Letter 2011-XX: Seismic... comment Draft Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors to inform addressees...

  10. New FDA draft guidance on immunogenicity.

    PubMed

    Parenky, Ashwin; Myler, Heather; Amaravadi, Lakshmi; Bechtold-Peters, Karoline; Rosenberg, Amy; Kirshner, Susan; Quarmby, Valerie

    2014-05-01

    A "Late Breaking" session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration's (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was initiated by a presentation from the FDA which highlighted several key aspects of the 2013 draft guidance pertaining to immunogenicity risk, the potential impact on patient safety and product efficacy, and risk mitigation. This was followed by an open discussion on the draft guidance which enabled delegates from biopharmaceutical companies to engage the FDA on topics that had emerged from their review of the draft guidance. The multidisciplinary audience fostered an environment that was conducive to scientific discussion on a broad range of topics such as clinical impact, immune mitigation strategies, immune prediction and the role of formulation, excipients, aggregates, and degradation products in immunogenicity. This meeting report highlights several key aspects of the 2013 draft guidance together with related dialog from the session.

  11. SSTAC/ARTS review of the draft Integrated Technology Plan (ITP). Volume 5: Human Support

    NASA Technical Reports Server (NTRS)

    1991-01-01

    Viewgraphs of briefings from the Space Systems and Technology Advisory Committee (SSTAC)/ARTS review of the draft integrated technology plan (ITP) on human support are included. Topics covered include: human support program; human factors; life support technology; fire safety; medical support technology; advanced refrigeration technology; EVA suit system; advanced PLSS technology; and ARC-EVA systems research program.

  12. 78 FR 67212 - Notice of Meeting of the Transit Rail Advisory Committee for Safety (TRACS)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... the safety of public transportation systems. DATES: The TRACS meeting will be held on November 21... Letter Report on the Development of the National Public Transportation Safety Plan (4) Review of the Draft Letter Report on Public Transportation Agency Plans (5) Public Comments (6) Wrap Up As previously...

  13. San Antonio Creek Restoration, Vandenberg Air Force Base, California

    DTIC Science & Technology

    2008-06-27

    Management (Section 4.5), Human Health and Safety (Section 4.6), Land Use and Aesthetics (Section 4.7), 1 FINAL DRAFT and Transportation...Environmental Assessment for the San Antonio Creek Restoration at Vandenberg Air Force Base, California Environmental, Safety , and Occupational Health...Environmental, Safety , and Occupational Health Council Vandenberg AFB, CA MAJCOM Approval

  14. 78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-20

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital... requirements for the quality and reliability of basic components with embedded digital devices. DATES: Submit...

  15. 76 FR 64353 - Request for Public Comment on Draft Document: “Criteria for a Recommended Standard: Occupational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC...: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control..., Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention...

  16. Evaluating performance of a Lead Road Safety Agency (LRSA) in a low-income country: a case study from Pakistan.

    PubMed

    Bhatti, Junaid A; Ahmed, Aizaz

    2014-01-01

    The World Health Organization recommends identifying a Lead Road Safety Agency (LRSA) within the government to coordinate preventive interventions. As LRSAs in developing countries have rarely been evaluated, this case study describes the performance of the LRSA of Pakistan with respect to the World Bank criteria. The designated LRSA, the National Road Safety Secretariat, was put into operation in 2006 and worked for about two years with World Bank funding. The agency had a stand-alone structure headed by an experienced road safety specialist during the first year only and faced difficulty in recruiting other required experts. The LRSA drafted the first National Road Safety Plan, including strategic review of road safety and existing legislation, articulated multisectorial collaboration nationally and provincially, and collected traffic injury data in some districts. Its progress was halted by its dissolution because of funding problems. Currently, two agencies specialising in traffic enforcement and transport research respectively are fulfilling LRSA functions on an ad-hoc basis. Results suggest that sustainability and consistency of LRSAs in developing countries like Pakistan may only be ensured if they are legally protected, inter-ministerial, have permanent funding and are provided with the required expertise through international cooperation, so they can perform their required functions effectively.

  17. Warrants, design, and safety of road ranger service patrols : draft final report.

    DOT National Transportation Integrated Search

    2016-11-01

    This research project created a decision support system for managers who must decide if a roadway warrants the addition of the Safety Service Patrol (SSP). Meetings with Florida Department of Transportation (FDOT) service patrol program manager...

  18. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

  19. [International trend of guidance for nanomaterial risk assessment].

    PubMed

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  20. The clinical development process for a novel preventive vaccine: An overview.

    PubMed

    Singh, K; Mehta, S

    2016-01-01

    Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

  1. Joint Planning and Development Office Work Plan FY10

    DTIC Science & Technology

    2010-01-01

    IPSA ) Division will make refinements to the NextGen Portfolio Analysis. In addition, IPSA will work with the Department of Defense (DoD) to define and...Submitted Interagency Portfolio and Systems Analysis ( IPSA ) DRAFT DoD Portfolio Analysis Criteria BASELINE DoD Portfolio Analysis Criteria DRAFT...WG Work Plan Review Prototype Capability Selected and Defined CHAs Complete Safety Metrics for IPSA Complete FINAL Prototype Report FINAL

  2. 76 FR 3646 - Safety Requirements and Manning Exemption Eligibility on Distant Water Tuna Fleet Vessels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ...Pursuant to Section 904 of the 2010 Coast Guard Authorization Act, the Coast Guard announces the availability of a draft policy regarding distant water tuna fleet vessels manning exemption eligibility and safety requirements. We request your comments on the Safety Requirements and Manning Exemption Eligibility on Distant Water Tuna Fleet Vessels.

  3. 76 FR 31507 - Domestic Licensing of Source Material-Amendments/Integrated Safety Analysis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... Licensing of Source Material--Amendments/Integrated Safety Analysis AGENCY: Nuclear Regulatory Commission... rule announced the availability of a draft regulatory analysis for public comment. This document... in Section XI, ``Regulatory Analysis.'' The correct ADAMS accession number is ML102380243. DATES: The...

  4. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Unwin, Stephen D.; Lowry, Peter P.; Layton, Robert F.

    This is a working report drafted under the Risk-Informed Safety Margin Characterization pathway of the Light Water Reactor Sustainability Program, describing statistical models of passives component reliabilities.

  5. Draft Genome Sequences of Five Neonatal Meningitis-Causing Escherichia coli Isolates (SP-4, SP-5, SP-13, SP-46, and SP-65)

    PubMed Central

    Xu, Aixia; Johnson, James R.; Sheen, Shiowshuh

    2018-01-01

    ABSTRACT Neonatal meningitis-causing Escherichia coli isolates (SP-4, SP-5, SP-13, SP-46, and SP-65) were recovered between 1989 and 1997 from infants in the Netherlands. Here, we report the draft genome sequences of these five E. coli isolates, which are currently being used to validate food safety processing technologies. PMID:29674529

  6. Draft genome sequences of six neonatal meningitis-causing escherichia coli isolates (SP-4, SP-5, SP-13, SP-16, SP-46, and SP-65)

    USDA-ARS?s Scientific Manuscript database

    Neonatal meningitis Escherichia coli isolates (SP-4, SP-5, SP-13, SP-16, SP-46, and SP-65) were recovered from infants in the Netherlands from 1989 to 1997. Here, we report the draft genome sequences for these six E. coli isolates, which are currently being used to validate food safety processing te...

  7. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

  8. 76 FR 38680 - Notice of Availability of the Draft Environmental Impact Statement for the West Chocolate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... solar, wind and geothermal testing and development in a renewable energy evaluation area located near... pending geothermal lease application within the renewable energy evaluation area. This CDCA Draft Plan... Availability of the Draft Environmental Impact Statement for the West Chocolate Mountains Renewable Energy...

  9. Draft evidence report : traumatic brain injury and commercial motor vehicle driver safety (comprehensive review).

    DOT National Transportation Integrated Search

    2009-03-30

    Purpose of this evidence report is to address several key questions posed by the Federal Motor Carrier Safety Administration : Key question 1: What is the impact of traumatic brain injury on crash risk/driving performance? Key question 2: What factor...

  10. 77 FR 38789 - Notice of Availability of Draft Waste Incidental to Reprocessing Evaluation for the Concentrator...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-29

    ... DEPARTMENT OF ENERGY Notice of Availability of Draft Waste Incidental to Reprocessing Evaluation...: Notice of availability. SUMMARY: The Department of Energy (DOE) announces the availability of a draft... Center in West Valley, New York, are waste incidental to reprocessing and thus are not high-level...

  11. Draft evidence report : diabetes and commercial motor vehicle driver safety (expedited review) : June 7, 2006.

    DOT National Transportation Integrated Search

    2006-06-07

    This report was prepared by ECRI under subcontract to MANILA Consulting Group, Inc., which holds prime Contract No. GS-10F-0177N/DTMC75-05-F-00062 with the Department of Transportations Federal Motor Carrier Safety Administration. ECRI is an indep...

  12. Draft final report : musculoskeletal disorders II, spinal cord injury and commercial motor vehicle driver safety (comprehensive review).

    DOT National Transportation Integrated Search

    2009-03-20

    This report was prepared by ECRI Institute under subcontract to MANILA Consulting Group, Inc., which holds prime GS-10F-0177N/DTMC75-06-F-00039 with the Department of Transportations Federal Motor Carrier Safety Administration. ECRI Institute is a...

  13. 76 FR 13410 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-11

    ... and their culture of patient safety. This survey is designed for use in community/retail pharmacies... on Patient Safety Culture Questionnaire; (2) Pretest and modify the questionnaire as necessary; (3... interview guide will be used for each round. (2) Pretest--The draft questionnaire will be pretested with all...

  14. 78 FR 49735 - Intent To Prepare a Draft Environmental Impact Statement for Dam Safety Study, Lake Lewisville...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-15

    ... determine appropriate permanent methods for correcting potential problems, interim risk reduction measures... Environmental Impact Statement for Dam Safety Study, Lake Lewisville Dam, Elm Fork Trinity River, Denton County... primary purposes of the project are flood risk management, [[Page 49736

  15. 78 FR 8119 - Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    ... the Herbert Hoover Dike Major Rehabilitation Project, Martin and Palm Beach Counties AGENCY...-wide risk reduction approach as required for safety modifications to dams. FOR FURTHER INFORMATION...-2108. SUPPLEMENTARY INFORMATION: The supplemental MRR will be replaced with a system-wide Dam Safety...

  16. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...

  17. [Critical evaluation of the first draft of DSM-V].

    PubMed

    Frances, A

    2011-02-16

    Critical evaluation of DSM-V first draft This is an evaluation of the first DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) draft from the DSM-IV chairman. First, a brief history of DSM is reported. Then, major reasons for present controversies and the threat they raise to APA leadership in the field are discussed. Third point is careful recollection of the several conflicting aspects of the DSM-V draft, paying attention to drawbacks and their implications for future clinical practice, research and forensic activity. Comment is finally provided about APA (American Psychiatric Association) decisions aimed at reaching more consensus about this basic instrument of American psychiatry.

  18. 75 FR 63345 - Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Increased Safety Measures for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... with a wide range of experts in state and Federal governments, academic institutions, and industry and... measures and performance-based standards recommended in the Safety Measures Report will be analyzed for... government, academic institutions, and industry and advocacy organizations. In addition, draft...

  19. 77 FR 50722 - Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Unit Testing for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1208, ``Software Unit Testing for Digital Computer Software used in Safety Systems of Nuclear Power Plants.'' The DG-1208 is proposed...

  20. 29 CFR 1918.62 - Miscellaneous auxiliary gear.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... appendix II to this part. A design safety factor of at least five shall be maintained for the common sizes... cranes, designed to be used with lesser wire rope safety factors; (ii) According to design factors in... pre-slung drafts. (3) Eye splices shall consist of at least three full tucks. Short splices shall...

  1. 29 CFR 1918.62 - Miscellaneous auxiliary gear.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... appendix II to this part. A design safety factor of at least five shall be maintained for the common sizes... cranes, designed to be used with lesser wire rope safety factors; (ii) According to design factors in... pre-slung drafts. (3) Eye splices shall consist of at least three full tucks. Short splices shall...

  2. 78 FR 8119 - Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    ... the Herbert Hoover Dike Major Rehabilitation Project, Palm Beach and Glades Counties, FL AGENCY... safety modifications to dams. FOR FURTHER INFORMATION CONTACT: Questions may be forwarded to Ms. Angela... supplemental MRR will be replaced with a system wide Dam Safety Modification (DSM) Report. Environmental...

  3. Studies on the exercise physiology of draft horses performed in Japan during the 1950s and 1960s.

    PubMed

    Hiraga, Atsushi; Sugano, Shigeru

    2017-01-01

    Although the total number of horses raised in Japan dramatically decreased after World War II, because draft horses were still used for farm work in paddy fields and on farms during the period of the 1950s and 1960s, a performance test for selecting better draft horses was needed. In order to determine the most suitable size of draft horses for Japanese farm conditions, the working power of horses weighing from 185 to 622 kg was evaluated by performing an endurance test, several kinds of working power tests, and maximum pulling power tests. Oxygen consumption during draft exercise was measured by the Douglas bag method in order to evaluate effects of draft workload under the conditions of different types of work (14- and 18-cm plow depths, cultivator, and tillage), traction methods (shoulder traction, shoulder-trunk traction, and chest-trunk traction), walking speeds (40, 60, 80, 100, and 120 m/min), and depths of water (0, 18, 36, and 54 cm) on energy expenditure. The relationship between energy consumption and pulse rate during exercise was also evaluated. A study of a performance test for draft horses was conducted to establish a new approach for evaluating draft horse performance using heart rate as an index. For this study, a beat meter for measuring heart rate was developed, and experimental protocols were used to evaluate the relationship between heart rate and workload. Although the research results obtained from these studies do not have particular relevance in the current day, these studies are valuable for understanding the history of equine exercise physiology in Japan.

  4. Studies on the exercise physiology of draft horses performed in Japan during the 1950s and 1960s

    PubMed Central

    HIRAGA, Atsushi; SUGANO, Shigeru

    2017-01-01

    ABSTRACT Although the total number of horses raised in Japan dramatically decreased after World War II, because draft horses were still used for farm work in paddy fields and on farms during the period of the 1950s and 1960s, a performance test for selecting better draft horses was needed. In order to determine the most suitable size of draft horses for Japanese farm conditions, the working power of horses weighing from 185 to 622 kg was evaluated by performing an endurance test, several kinds of working power tests, and maximum pulling power tests. Oxygen consumption during draft exercise was measured by the Douglas bag method in order to evaluate effects of draft workload under the conditions of different types of work (14- and 18-cm plow depths, cultivator, and tillage), traction methods (shoulder traction, shoulder-trunk traction, and chest-trunk traction), walking speeds (40, 60, 80, 100, and 120 m/min), and depths of water (0, 18, 36, and 54 cm) on energy expenditure. The relationship between energy consumption and pulse rate during exercise was also evaluated. A study of a performance test for draft horses was conducted to establish a new approach for evaluating draft horse performance using heart rate as an index. For this study, a beat meter for measuring heart rate was developed, and experimental protocols were used to evaluate the relationship between heart rate and workload. Although the research results obtained from these studies do not have particular relevance in the current day, these studies are valuable for understanding the history of equine exercise physiology in Japan. PMID:28400701

  5. A FRAME response to the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects--2010.

    PubMed

    Balls, Michael; Clothier, Richard

    2010-10-01

    This response on behalf of FRAME to the European Commission's consultation on the five chapters of the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects--2010, is via a Comment in ATLA, rather than via the template supplied by the Commission. This is principally so that a number of general points about cosmetic ingredient testing can be made. It is concluded that the five draft chapters do not provide a credible basis for the Commission's forthcoming report to the European Parliament and the European Council on the five cosmetic ingredient safety issues for which the 7th Amendment to the Cosmetic Directive's ban on animal testing was postponed until 2013. This is mainly because there is insufficient focus in the draft chapters on the specific nature of cosmetic ingredients, their uses, their local effects and metabolism at their sites of application, and, in particular, on whether their possible absorption into the body would be likely to lead to their accumulation in target sites at levels approaching Thresholds of Toxicological Concern. Meanwhile, there continues to be uncertainty about how the provisions of the Cosmetics Directive should be applied, given the requirements of the REACH system and directives concerned with the safety of other chemicals and products. © 2010 FRAME.

  6. 75 FR 9188 - Intent To Prepare a Draft Environmental Impact Statement for the Everglades Restoration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... evaluation of relevant new species information and hydrological data. The ERTP Draft EIS will evaluate the... alternative and actual data collected since the May 2002 FEIS. The IOP was intended to be continued until the... agency in the preparation of the Draft EIS. The Corps is in close coordination with the FWS. The Corps...

  7. Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review.

    PubMed

    Sheehan, David V; Giddens, Jennifer M; Sheehan, Kathy Harnett

    2014-09-01

    Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria. A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored. The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time. These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality.

  8. 33 CFR 165.T09-1080 - Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... vessels are prohibited from transiting the safety zone with any non-potable water on board if they intend to release that water in any form within, or on the other side of the safety zone. Non-potable water includes but is not limited to any water taken on board to control or maintain trim, draft, stability or...

  9. 33 CFR 165.T09-1054 - Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... safety zone with any non-potable water on board if they intend to release that water in any form within, or on the other side of the safety zone. Non-potable water includes but is not limited to any water taken on board to control or maintain trim, draft, stability or stresses of the vessel, or taken on...

  10. 78 FR 65622 - Notice of Availability for the Draft Environmental Impact Statement and Announcement of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ... DEPARTMENT OF ENERGY [OE Docket No. PP-362] Notice of Availability for the Draft Environmental.... SUMMARY: The U.S. Department of Energy (DOE) announces the availability of the ``Draft Environmental... EIS. The Draft EIS evaluates the environmental impacts of DOE's proposed Federal action of issuing a...

  11. The new World Organisation for Animal Health standards on avian influenza and international trade.

    PubMed

    Thiermann, Alex B

    2007-03-01

    In 2002, the World Organisation for Animal Health began a review of the chapter on avian influenza by convening a group of experts to revise the most recent scientific literature. The group drafted the initial text that would provide the necessary recommendations on avian influenza control and prevention measures. The main objectives of this draft were to provide clear notification criteria, as well as commodity-specific, risk-based mitigating measures, that would provide safety when trading and encourage transparent reporting.

  12. [A preliminary mapping methodology for occupational hazards and biomechanical risk evaluation: presentation of a simple, computerized tool kit for ergonomic hazards identification and risk assessment].

    PubMed

    Colombini, Daniela; Occhipinti, E; Di Leone, G

    2011-01-01

    During the last Congress of the International Ergonomics Association (IEA), Beijing, August 2009, an international group was founded with the task of developing a "toolkit for MSD prevention" under the IEA and in collaboration with the World Health Organization. The possible users of toolkits are: members of health and safety committees; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers providing basic occupational health services; occupational health and safety specialists. According to the ISO standard 11228 series and the new Draft CD ISO 12259-2009: Application document guides for the potential user, our group developed a preliminary "mapping" methodology of occupational hazards in the craft industry, supported by software (Excel). The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazards identification and risk estimation to be made. It is thus possible to decide for which occupational hazards a more exhaustive risk assessment will be necessary and which occupational consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).

  13. 78 FR 40396 - Safety Zone; America's Cup Safety Zone and No Loitering Area, San Francisco, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-05

    ... were issued for this series of races. Only after the Coast Guard learned that the racing vessels.... Additionally, members of the deep-draft commercial shipping community raised concerns pertaining to the... associated with the viewing of the America's Cup in vicinity of buoys ``1'' and ``2'', marking the deep water...

  14. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1145... strategies that can be used in clinical trials intended to support effectiveness and safety claims in new...

  15. 78 FR 58470 - General Technical, Organizational, and Conforming Amendments to the Federal Motor Carrier Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ..., 355, 365, 369, 370, 372, 375, 376, 380, 381, 382, 383, 384, 385, 386, 387, 389, 390, 391, 393, 395... Drafting Handbook,'' page 2-45. Part 389 Section 389.25. Section 389.25 is revised to correct typographical... recordkeeping requirements, Surety bonds. 49 CFR Part 389 Administrative practice and procedure, Highway safety...

  16. 78 FR 33144 - Meeting: RTCA Program Management Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ... by SC-227. Final Draft, New Document, Operational and Functional Requirements and Safety Objectives... & Synthetic Vision Systems-- Discussion--Revised Terms of Reference. SC-214--Standards for Air Traffic Data...

  17. 77 FR 58416 - Comparative Environmental Evaluation of Alternatives for Handling Low-Level Radioactive Waste...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0218] Comparative Environmental Evaluation of Alternatives... public comment the Draft Comparative Environmental Evaluation of Alternatives for Handling Low-Level.... Availability of Documents ADAMS Accession No. Document title ML12256A965 Draft Comparative Environmental...

  18. OVERVIEW OF THE DRAFT METHODOLOGY FOR CONDUCTING BIOLOGICAL EVALUATIONS OF AQUATIC LIFE CRITERIA

    EPA Science Inventory

    This presentation will provide an overview of the draft methodology used in developing biological evaluations of aquatic life criteria specifically addressing aquatic and aquatic-dependent threatened and endangered species.

  19. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in... entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific...

  20. The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

    PubMed

    Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark

    2005-12-01

    Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

  1. Evaluation of the Cranial Cruciate Ligament Repair System® in Surgery for Laryngeal Hemiplegia in Heavy Draft Horses

    PubMed Central

    SASAKI, Naoki; MORITA, Yoshinori; MORIYAMA, Tomoe; YAMADA, Haruo

    2009-01-01

    The purpose of this study was to evaluate the effect of the canine cranial cruciate ligament repair system on laryngeal hemiplegia in heavy draft horses. Twenty-four heavy draft horses diagnosed with grade 4 laryngeal hemiplegia were allocated to either the prosthetic laryngoplasty (PL) group (n=14) or a canine cranial cruciate ligament repair system (CCCLRS) group (n=10). Right to left angle quotients (RLQs) of abductions of the arytenoid cartilages were endoscopically evaluated before and after surgery. Post-operative RLQs in the CCCLRS group were significantly lower than those of the PL group (P<0.01). The canine cranial cruciate ligament repair system was revealed to be a good surgical procedure for laryngeal hemiplegia in heavy draft horses. PMID:24833966

  2. 49 CFR 215.129 - Defective cushioning device.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.129 Defective cushioning device. A railroad may not place or continue in service a car if it...

  3. 49 CFR 215.129 - Defective cushioning device.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.129 Defective cushioning device. A railroad may not place or continue in service a car if it...

  4. 49 CFR 215.129 - Defective cushioning device.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.129 Defective cushioning device. A railroad may not place or continue in service a car if it...

  5. 49 CFR 215.129 - Defective cushioning device.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.129 Defective cushioning device. A railroad may not place or continue in service a car if it...

  6. 49 CFR 215.129 - Defective cushioning device.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.129 Defective cushioning device. A railroad may not place or continue in service a car if it...

  7. 78 FR 33447 - Draft Applications for Sealed Source and Device Evaluation and Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0104] Draft Applications for Sealed Source and Device... for sealed source and device evaluation and registration. The NRC is requesting public comment on... for Sealed Source and Device Evaluation and Registration.'' The document has been updated from the...

  8. 23 CFR 771.129 - Re-evaluations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... RELATED PROCEDURES § 771.129 Re-evaluations. (a) A written evaluation of the draft EIS shall be prepared by the applicant in cooperation with the Administration if an acceptable final EIS is not submitted to the Administration within three years from the date of the draft EIS circulation. The purpose of...

  9. Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.

    PubMed

    Hukkanen, Renee R; Halpern, Wendy G; Vidal, Justin D

    2016-10-01

    In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents. © The Author(s) 2016.

  10. Towards an International Classification for Patient Safety: the conceptual framework.

    PubMed

    Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

    2009-02-01

    Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose.

  11. Towards an International Classification for Patient Safety: the conceptual framework

    PubMed Central

    Sherman, Heather; Castro, Gerard; Fletcher, Martin; Hatlie, Martin; Hibbert, Peter; Jakob, Robert; Koss, Richard; Lewalle, Pierre; Loeb, Jerod; Perneger, Thomas; Runciman, William; Thomson, Richard; Van Der Schaaf, Tjerk; Virtanen, Martti

    2009-01-01

    Global advances in patient safety have been hampered by the lack of a uniform classification of patient safety concepts. This is a significant barrier to developing strategies to reduce risk, performing evidence-based research and evaluating existing healthcare policies relevant to patient safety. Since 2005, the World Health Organization's World Alliance for Patient Safety has undertaken the Project to Develop an International Classification for Patient Safety (ICPS) to devise a classification which transforms patient safety information collected from disparate systems into a common format to facilitate aggregation, analysis and learning across disciplines, borders and time. A drafting group, comprised of experts from the fields of patient safety, classification theory, health informatics, consumer/patient advocacy, law and medicine, identified and defined key patient safety concepts and developed an internationally agreed conceptual framework for the ICPS based upon existing patient safety classifications. The conceptual framework was iteratively improved through technical expert meetings and a two-stage web-based modified Delphi survey of over 250 international experts. This work culminated in a conceptual framework consisting of ten high level classes: incident type, patient outcomes, patient characteristics, incident characteristics, contributing factors/hazards, organizational outcomes, detection, mitigating factors, ameliorating actions and actions taken to reduce risk. While the framework for the ICPS is in place, several challenges remain. Concepts need to be defined, guidance for using the classification needs to be provided, and further real-world testing needs to occur to progressively refine the ICPS to ensure it is fit for purpose. PMID:19147595

  12. Alcohol ignition interlock service support

    DOT National Transportation Integrated Search

    1992-12-01

    Author's abstract: This Technical Report was produced under Contract No. DTNH22-89-C-07009 for the National Highway Traffic Safety Administration. Under that same contract, a draft set of model specifications for Breath Alcohol Ignition Interlock Dev...

  13. Systematic identification of high crash locations.

    DOT National Transportation Integrated Search

    2011-05-01

    Federal and state policy makers increasingly emphasize the need to reduce highway crash rates. This emphasis is demonstrated in Iowa's recently released draft Iowa Strategic Highway Safety Plan and by the U.S. Department of Transportation's placement...

  14. Selection of representative embankments based on rough set - fuzzy clustering method

    NASA Astrophysics Data System (ADS)

    Bin, Ou; Lin, Zhi-xiang; Fu, Shu-yan; Gao, Sheng-song

    2018-02-01

    The premise condition of comprehensive evaluation of embankment safety is selection of representative unit embankment, on the basis of dividing the unit levee the influencing factors and classification of the unit embankment are drafted.Based on the rough set-fuzzy clustering, the influence factors of the unit embankment are measured by quantitative and qualitative indexes.Construct to fuzzy similarity matrix of standard embankment then calculate fuzzy equivalent matrix of fuzzy similarity matrix by square method. By setting the threshold of the fuzzy equivalence matrix, the unit embankment is clustered, and the representative unit embankment is selected from the classification of the embankment.

  15. Integrated Science Assessment (ISA) for Lead (First External Review Draft, May 2011)

    EPA Science Inventory

    EPA announced that the First External Review Draft of the Integrated Science Assessment (ISA) for Lead (Pb) was made available for independent peer review and public review. This draft ISA represents a concise synthesis and evaluation of the most policy-relevant science and will ...

  16. Integrated Science Assessment (ISA) for Carbon Monoxide (Second External Review Draft, Sep 2009)

    EPA Science Inventory

    EPA announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Carbon Monoxide (CO) and related Annexes was made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation of t...

  17. Integrated Science Assessment (ISA) for Carbon Monoxide (First External Review Draft, Mar 2009)

    EPA Science Inventory

    EPA announced that the First External Review Draft of the Integrated Science Assessment (ISA) for Carbon Monoxide (CO) and related Annexes was made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation of th...

  18. 77 FR 52024 - Notification of a Public Teleconference of the Chartered Science Advisory Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Amphibole Asbestos and (2) an SAB draft report regarding EPA's Scientific and Technological Achievement... review of an SAB draft report reviewing EPA's Toxicological Review of Libby Amphibole Asbestos. The... entitled ``Toxicological Review of Libby Amphibole Asbestos.'' The EPA's draft assessment evaluates cancer...

  19. Integrated Science Assessment (ISA) for Oxides of Nitrogen – Health Criteria (Second External Review Draft, 2008)

    EPA Science Inventory

    EPA has announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Oxides of Nitrogen – Health Criteria has been made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation...

  20. Integrated Science Assessment (ISA) for Lead (Second External Review Draft, Mar 2012)

    EPA Science Inventory

    EPA has announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Lead (Pb) has been made available for independent peer review and public review. This draft ISA represents a concise synthesis and evaluation of the most policy-relevant science...

  1. Integrated Science Assessment (ISA) for Lead (Third External Review Draft, Nov 2012)

    EPA Science Inventory

    EPA announced that the Third External Review Draft of the Integrated Science Assessment (ISA) for Lead (Pb) was made available for independent peer review and public review. This draft ISA represents a concise synthesis and evaluation of the most policy-relevant science and will ...

  2. Integrated Science Assessment (ISA) of Ozone and Related Photochemical Oxidants (First External Review Draft, Feb 2011)

    EPA Science Inventory

    EPA announced that the First External Review Draft of the Integrated Science Assessment for Ozone and Related Photochemical Oxidants has been made available for independent peer review and public review. This draft document represents a concise synthesis and evaluation of ...

  3. Integrated Science Assessment (ISA) of Ozone and Related Photochemical Oxidants (Second External Review Draft, Sep 2011)

    EPA Science Inventory

    EPA has released the Integrated Science Assessment of Ozone and Related Photochemical Oxidants (Second External Review Draft) for independent peer review and public review. This draft document represents a concise synthesis and evaluation of the most policy-relevant scienc...

  4. Integrated Science Assessment (ISA) of Ozone and Related Photochemical Oxidants (Third External Review Draft, Jun 2012)

    EPA Science Inventory

    EPA has released the Integrated Science Assessment of Ozone and Related Photochemical Oxidants (Third External Review Draft) for independent peer review and public review. This draft document represents a concise synthesis and evaluation of the most policy-relevant science...

  5. Evaluation of Resuspension from Propeller Wash in DoD Harbors

    DTIC Science & Technology

    2016-05-01

    RESUSPENSION CHARACTERIZATION ............................................................. 11 5.3 DEEP -DRAFT RESUSPENSION STUDY IN PEARL HARBOR...RESUSPENSION FROM A DEEP -DRAFT VESSEL .............................................. 21 6.4.1 Field Observations Using ADCP...event resulted in validation of the FANS model for prediction of sediment resuspension by a deep draft vessel. While working on the resuspension

  6. 78 FR 76140 - Extension of Public Comment Period for the Champlain Hudson Power Express Transmission Line...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Transmission Line Project Draft Environmental Impact Statement AGENCY: Department of Energy. ACTION: Extension... comment period for the Champlain Hudson Power Express Transmission Line Project Draft Environmental Impact Statement (DOE/EIS-0447). The Draft EIS evaluates the environmental impacts of DOE's proposed Federal action...

  7. 75 FR 43172 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and... availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use...

  8. Quantitative and qualitative analysis on the legislative production relating to healthcare in passage in the National Congress in the years 2007 and 2008.

    PubMed

    Santos, Viviane Cristina dos; Ferraz, Marcos Bosi

    2013-01-01

    The Federal Constitution of 1988 allowed the National Congress to contribute towards formulation of new public policies. The objective of this study was to analyze the legislative production that dealt with health issues that was in passage in the National Congress between January 2007 and December 2008. Descriptive-exploratory cross-sectional study with quantitative and qualitative approaches, conducted in a federal university. The analysis material for the study comprised 144 draft bills that were classified and subsequently randomly evaluated by 155 professionals working within the healthcare system. The analysis showed that the Workers' Party (PT) and Brazilian Democratic Movement Party (PMDB) were the parties that presented the largest proportions of the draft bills (12.5% and 11.1%); 25.4% of the draft bills were presented by congress members with academic qualifications within healthcare and only 1.4% of the draft bills became transformed into legal regulations. In questionnaire responses, 51.5% of the evaluators did not consider the draft bills to be viable, 40.6% did not consider them to be relevant and 52.5% said that if the draft bills were not approved it would not be harmful to Brazilian society. In analyzing the data from this study, it was noted that the legislative production relating to healthcare was low and the transformation rate from draft bill to legal regulation was negligible. The results from the evaluation showed that the quality of legislative production was impaired.

  9. Development of a patient safety climate survey for Chinese hospitals: cross-national adaptation and psychometric evaluation.

    PubMed

    Zhu, Junya; Li, Liping; Zhao, Hailei; Han, Guangshu; Wu, Albert W; Weingart, Saul N

    2014-10-01

    Existing patient safety climate instruments, most of which have been developed in the USA, may not accurately reflect the conditions in the healthcare systems of other countries. To develop and evaluate a patient safety climate instrument for healthcare workers in Chinese hospitals. Based on a review of existing instruments, expert panel review, focus groups and cognitive interviews, we developed items relevant to patient safety climate in Chinese hospitals. The draft instrument was distributed to 1700 hospital workers from 54 units in six hospitals in five Chinese cities between July and October 2011, and 1464 completed surveys were received. We performed exploratory and confirmatory factor analyses and estimated internal consistency reliability, within-unit agreement, between-unit variation, unit-mean reliability, correlation between multi-item composites, and association between the composites and two single items of perceived safety. The final instrument included 34 items organised into nine composites: institutional commitment to safety, unit management support for safety, organisational learning, safety system, adequacy of safety arrangements, error reporting, communication and peer support, teamwork and staffing. All composites had acceptable unit-mean reliabilities (≥0.74) and within-unit agreement (Rwg ≥0.71), and exhibited significant between-unit variation with intraclass correlation coefficients ranging from 9% to 21%. Internal consistency reliabilities ranged from 0.59 to 0.88 and were ≥0.70 for eight of the nine composites. Correlations between composites ranged from 0.27 to 0.73. All composites were positively and significantly associated with the two perceived safety items. The Chinese Hospital Survey on Patient Safety Climate demonstrates adequate dimensionality, reliability and validity. The integration of qualitative and quantitative methods is essential to produce an instrument that is culturally appropriate for Chinese hospitals. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. 77 FR 43514 - Anchorage Regulations; Narragansett Bay and Rhode Island Sound, RI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-25

    ... learned that with the withdrawal of the Weaver's Cove LNG proposal, and there being no other LNG proposals... improves safety for vessels using the anchorage grounds, facilitates the transit of deep draft vessels...

  11. Junior high school occupant protection materials

    DOT National Transportation Integrated Search

    1989-09-06

    Based on a review of existing occupant protection materials, discussions with panel of subject experts and teachers, and a series of pilot tests, a set of (draft) curriculum materials on occupant safety was developed for junior high school students. ...

  12. [Ethics and biomedical research].

    PubMed

    Goussard, Christophe

    2007-01-01

    Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.

  13. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... your comment on this draft guidance before it begins work on the final version of the guidance, submit... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm...

  14. 23 CFR 771.123 - Draft environmental impact statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Notice of Intent, the lead agencies, in cooperation with the applicant (if not a lead agency), will begin... at the local level. (c) The draft EIS shall be prepared by the lead agencies, in cooperation with the applicant (if not a lead agency). The draft EIS shall evaluate all reasonable alternatives to the action and...

  15. 23 CFR 771.123 - Draft environmental impact statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Notice of Intent, the lead agencies, in cooperation with the applicant (if not a lead agency), will begin... at the local level. (c) The draft EIS shall be prepared by the lead agencies, in cooperation with the applicant (if not a lead agency). The draft EIS shall evaluate all reasonable alternatives to the action and...

  16. How Learners Use Automated Computer-Based Feedback to Produce Revised Drafts of Essays

    ERIC Educational Resources Information Center

    Laing, Jonny; El Ebyary, Khaled; Windeatt, Scott

    2012-01-01

    Our previous results suggest that the use of "Criterion", an automatic writing evaluation (AWE) system, is particularly successful in encouraging learners to produce amended drafts of their essays, and that those amended drafts generally represent an improvement on the original submission. Our analysis of the submitted essays and the…

  17. 75 FR 69078 - Workshop To Review Draft Materials for the Lead (Pb) Integrated Science Assessment (ISA)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9224-7] Workshop To Review Draft Materials for the Lead (Pb) Integrated Science Assessment (ISA) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Workshop... (NAAQS) for Lead (Pb), EPA is announcing that a workshop to evaluate initial draft materials for the Pb...

  18. Integrated Science Assessment (ISA) for Oxides of Nitrogen – Health Criteria (First External Review Draft, 2013)

    EPA Science Inventory

    EPA is announcing the availability of the First External Review Draft of the Integrated Science Assessment for Oxides of Nitrogen – Health Criteria for public comment and independent peer review. This draft document provides EPA’s evaluation and synthesis of the most polic...

  19. 78 FR 39253 - Notice of Extension of Comment Period for Draft Initial Comprehensive Plan and Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ...Pursuant to the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf States Act (RESTORE Act), the Secretary of Commerce, as Chair of the Gulf Coast Ecosystem Restoration Council (Council), announces the extension of the public comment period for the Draft Initial Comprehensive Plan (Draft Plan) to restore and protect the Gulf Coast region and the Draft Programmatic Environmental Assessment (Draft PEA) for the Draft Plan. Council Members also have compiled preliminary lists of ecosystem restoration projects that are ``authorized but not yet commenced'' and the full Council is in the process of evaluating these lists; the Council announces the availability of these preliminary lists. If you previously submitted comments, please do not resubmit them because the Council has already incorporated them into the public record and will fully consider them.

  20. 77 FR 41442 - Notice of Availability of the Draft Order of the Secretary on Oil and Gas and Potash Development...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... protection of other mineral resources, other natural resources, environmental quality, life, health, safety... sufficient thickness and quality to be mineable), the Development Areas would generally be larger...

  1. A Multidisciplinary Research Team Approach to Computer-Aided Drafting (CAD) System Selection. Final Report.

    ERIC Educational Resources Information Center

    Franken, Ken; And Others

    A multidisciplinary research team was assembled to review existing computer-aided drafting (CAD) systems for the purpose of enabling staff in the Design Drafting Department at Linn Technical College (Missouri) to select the best system out of the many CAD systems in existence. During the initial stage of the evaluation project, researchers…

  2. 75 FR 12171 - Notice of Availability of a Draft Pest Risk Assessment on Honey Bees Imported from Australia

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ...] Notice of Availability of a Draft Pest Risk Assessment on Honey Bees Imported from Australia AGENCY... evaluation of the pest risks associated with the importation of honey bees from Australia. The draft pest... States from Australia after concerns that exotic honey bee pathogens or parasites may have been...

  3. Surveying Florida MPO readiness to incorporate innovative technologies into long range transportation plans : draft final report.

    DOT National Transportation Integrated Search

    2016-08-01

    There is optimism that Automated Vehicles (AVs) can improve the safety of the transportation system, : reduce congestion, increase reliability, offer improved mobility solutions to all segments of the population : including the transportation-disadva...

  4. 75 FR 80083 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... the draft safety culture policy statement for medical licensees. Contingent upon the outcome of the..., 2011, 1 p.m. to 3 p.m. Eastern Standard Time (EST). The second teleconference meeting will be held on...

  5. 75 FR 70955 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... the draft safety culture policy statement for medical licensees. A copy of the agenda for the meeting... on Monday, December 13, 2010, from 1 p.m. to 4 p.m. Eastern Standard Time. Public Participation: Any...

  6. Accuracy of professional sports drafts in predicting career potential.

    PubMed

    Koz, D; Fraser-Thomas, J; Baker, J

    2012-08-01

    The forecasting of talented players is a crucial aspect of building a successful sports franchise and professional sports invest significant resources in making player choices in sport drafts. The current study examined the relationship between career performance (i.e. games played) and draft round for the National Football League, National Hockey League, National Basketball League, and Major League Baseball for players drafted from 1980 to 1989 (n = 4874) against the assumption of a linear relationship between performance and draft round (i.e. that players with the most potential will be selected before players of lower potential). A two-step analysis revealed significant differences in games played across draft rounds (step 1) and a significant negative relationship between draft round and games played (step 2); however, the amount of variance accounted for was relatively low (less than 17%). Results highlight the challenges of accurately evaluating amateur talent. © 2011 John Wiley & Sons A/S.

  7. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  8. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver..., Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

  9. 16 CFR 1021.8 - Legislative proposals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENVIRONMENTAL REVIEW Procedures § 1021.8... hearings and deliberations. The draft EIS shall be forwarded to the Environmental Protection Agency in accordance with § 1506.9 of the NEPA regulations. Comments on the legislative statement and CPSC's responses...

  10. 75 FR 32855 - Safety Zone; Pierce County, WA, Department of Emergency Management, Regional Water Exercise

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... restricting deep draft vessels from creating a wake near the exercise. DATES: This rule is effective from 7 a... exercise area, and from creating large wakes near the exercise. Discussion of Rule This rule establishes a...

  11. Commercial Economic Poisons Applicators Licensing Manual, Rough Draft.

    ERIC Educational Resources Information Center

    Michigan State Dept. of Agriculture, Lansing, Div. of Plant Industry.

    This pesticide manual gives information on types of pest management, labels and labeling of pesticide containers, safety, types of pesticides (including chapters on insecticides, fungicides, herbicides, and nematicides), spray equipment, identification of pests (including weeds, plant diseases, and vertebrates), and environmental considerations.…

  12. 16 CFR 1021.14 - Environmental impact statement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 1021.14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENVIRONMENTAL REVIEW Contents of Environmental Review Documents § 1021.14 Environmental impact statement. (a) Draft and final... which are not effects on the natural or physical environment, but rather are, for example, purely...

  13. 77 FR 31894 - Portable Gauge Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... include safety culture, security of radioactive materials, protection of sensitive information, a revised... draft NUREG and is especially interested in receiving comments on the examples and pictures used in... following questions regarding the examples and pictures in Appendix G: 1. Do the examples for two...

  14. 76 FR 57682 - Petition Requesting Regulations Restricting Cadmium in Children's Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... Requesting Regulations Restricting Cadmium in Children's Products AGENCY: Consumer Product Safety Commission...'') has received a petition requesting standards restricting cadmium in children's products, especially... to begin drafting a proposed rule unless a voluntary standard for cadmium in children's jewelry is...

  15. 75 FR 35508 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... Systems and Networks,'' requires licensees to develop cyber-security plans and programs to protect critical digital assets, including digital safety systems, from malicious cyber attacks. Regulatory Guide 5.71, ``Cyber Security Programs for Nuclear Facilities,'' provides guidance to meet the requirements of...

  16. ICSBEP Benchmarks For Nuclear Data Applications

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Briggs, J. Blair

    2005-05-24

    The International Criticality Safety Benchmark Evaluation Project (ICSBEP) was initiated in 1992 by the United States Department of Energy. The ICSBEP became an official activity of the Organization for Economic Cooperation and Development (OECD) -- Nuclear Energy Agency (NEA) in 1995. Representatives from the United States, United Kingdom, France, Japan, the Russian Federation, Hungary, Republic of Korea, Slovenia, Serbia and Montenegro (formerly Yugoslavia), Kazakhstan, Spain, Israel, Brazil, Poland, and the Czech Republic are now participating. South Africa, India, China, and Germany are considering participation. The purpose of the ICSBEP is to identify, evaluate, verify, and formally document a comprehensive andmore » internationally peer-reviewed set of criticality safety benchmark data. The work of the ICSBEP is published as an OECD handbook entitled ''International Handbook of Evaluated Criticality Safety Benchmark Experiments.'' The 2004 Edition of the Handbook contains benchmark specifications for 3331 critical or subcritical configurations that are intended for use in validation efforts and for testing basic nuclear data. New to the 2004 Edition of the Handbook is a draft criticality alarm / shielding type benchmark that should be finalized in 2005 along with two other similar benchmarks. The Handbook is being used extensively for nuclear data testing and is expected to be a valuable resource for code and data validation and improvement efforts for decades to come. Specific benchmarks that are useful for testing structural materials such as iron, chromium, nickel, and manganese; beryllium; lead; thorium; and 238U are highlighted.« less

  17. Preexisting Rotator Cuff Tears as a Predictor of Outcomes in National Football League Athletes.

    PubMed

    Gibbs, Daniel B; Lynch, T Sean; Gombera, M Mustafa; Saltzman, Matthew D; Nuber, Gordon W; Schroeder, Gregory D; Labelle, Mark; Hollett, Brian P

    A preexisting rotator cuff tear may affect the draft status and career performance of National Football League (NFL) players. Preexisting rotator cuff tears decrease a player's draft status, performance, and longevity in the NFL. Retrospective cohort study. Level 3. Medical reports of prospective NFL players during the NFL Scouting Combine from 2003 to 2011 were evaluated to identify players with a previous rotator cuff tear. Athletes were matched to control draftees without documented shoulder pathology by age, position, year drafted, and round drafted. Career statistics and performance scores were calculated. Between 2003 and 2011, 2965 consecutive athletes were evaluated. Forty-nine athletes had preexisting rotator cuff tears: 22 athletes underwent surgical intervention for their tear and 27 were treated nonoperatively. Those with a rotator cuff tear were significantly less likely to be drafted than those without a previous injury (55.1% vs 77.5%, P = 0.002). The 27 drafted athletes with preexisting rotator cuff tears started significantly fewer games (23.7 vs 43.0, P = 0.02) and played significantly fewer years (4.3 vs 5.7, P = 0.04) and significantly fewer games (47.1 vs 68.4, P = 0.04) than matched control athletes without rotator cuff tears. Athletes with a preexisting rotator cuff tear were less likely to be drafted and had decreased career longevity.

  18. Towards an International Classification for Patient Safety: a Delphi survey.

    PubMed

    Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

    2009-02-01

    Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. International web-based survey of expert opinion. Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur.

  19. Towards an International Classification for Patient Safety: a Delphi survey

    PubMed Central

    Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

    2009-01-01

    Objective Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Design Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. Setting International web-based survey of expert opinion. Participants Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. Results In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. Conclusions The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur. PMID:19147596

  20. Mars Sample Handling Protocol Workshop Series: Workshop 4

    NASA Technical Reports Server (NTRS)

    Race Margaret S. (Editor); DeVincenzi, Donald L. (Editor); Rummel, John D. (Editor); Acevedo, Sara E. (Editor)

    2001-01-01

    In preparation for missions to Mars that will involve the return of samples to Earth, it will be necessary to prepare for the receiving, handling, testing, distributing, and archiving of martian materials here on Earth. Previous groups and committees have studied selected aspects of sample return activities, but specific detailed protocols for the handling and testing of returned samples must still be developed. To further refine the requirements for sample hazard testing and to develop the criteria for subsequent release of sample materials from quarantine, the NASA Planetary Protection Officer convened a series of workshops in 2000-2001. The overall objective of the Workshop Series was to produce a Draft Protocol by which returned martian sample materials can be assessed for biological hazards and examined for evidence of life (extant or extinct) while safeguarding the purity of the samples from possible terrestrial contamination. This report also provides a record of the proceedings of Workshop 4, the final Workshop of the Series, which was held in Arlington, Virginia, June 5-7, 2001. During Workshop 4, the sub-groups were provided with a draft of the protocol compiled in May 2001 from the work done at prior Workshops in the Series. Then eight sub-groups were formed to discuss the following assigned topics: Review and Assess the Draft Protocol for Physical/Chemical Testing Review and Assess the Draft Protocol for Life Detection Testing Review and Assess the Draft Protocol for Biohazard Testing Environmental and Health/Monitoring and Safety Issues Requirements of the Draft Protocol for Facilities and Equipment Contingency Planning for Different Outcomes of the Draft Protocol Personnel Management Considerations in Implementation of the Draft Protocol Draft Protocol Implementation Process and Update Concepts This report provides the first complete presentation of the Draft Protocol for Mars Sample Handling to meet planetary protection needs. This Draft Protocol, which was compiled from deliberations and recommendations from earlier Workshops in the Series, represents a consensus that emerged from the discussions of all the sub-groups assembled over the course of the five Workshops of the Series. These discussions converged on a conceptual approach to sample handling, as well as on specific analytical requirements. Discussions also identified important issues requiring attention, as well as research and development needed for protocol implementation.

  1. Visualizing Revision: Leveraging Student-Generated Between-Draft Diagramming Data in Support of Academic Writing Development

    ERIC Educational Resources Information Center

    Olmanson, Justin; Kennett, Katrina; Magnifico, Alecia; McCarthey, Sarah; Searsmith, Duane; Cope, Bill; Kalantzis, Mary

    2016-01-01

    Once writers complete a first draft, they are often encouraged to evaluate their writing and prioritize what to revise. Yet, this process can be both daunting and difficult. This study looks at how students used a semantic concept mapping tool to re-present the content and organization of their initial draft of an informational text. We examine…

  2. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ...] Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment... topics regarding irritable bowel syndrome (IBS) sign and symptom assessment for IBS with diarrhea (IBS-D... IBS. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...

  3. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms May 13, 1947 to May 29, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Tolefson, Harold B.

    1948-01-01

    The gust and draft velocities evaluated from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from May 13 to May 29, 1947 are presented.

  4. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research..., Silver Spring, MD 20993- 0002, 301-796-8510. Regarding human drug products: Solomon Iyasu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm...

  5. Respiratory protection standard: comments on OSHA's proposed revision.

    PubMed

    Decker, M D

    1995-06-01

    On November 15, 1994, the Occupational Safety and Health Administration (OSHA) published in the Federal Register (59:58884-58956) the draft of a proposed revision of the Respiratory Protection Standard. One of OSHA's oldest standards, the Respiratory Protection Standard defines the conduct of the employer (eg, hospital) with respect to respirator training, fit testing, medical examinations, use, storage, and so on. The proposed revision appears to have been drafted with no consideration for its effect on healthcare workers or the healthcare industry. SHEA has prepared the following comments to OSHA, which have been submitted to the docket and will be presented at public hearings later this month.

  6. 76 FR 174 - NIJ Draft Metal Detector Standards for Public Safety

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-03

    ... online. Personal identifying information and confidential business information identified and located as... record and may be made available for public inspection online. Such information includes personal... do not wish for it to be posted online, you must include the phrase ``PERSONAL IDENTIFYING...

  7. 75 FR 11574 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... protection during plant operation and maintenance activities. For plants that have a design basis that... coatings be qualified and capable of surviving a design-basis accident without adversely affecting safety...

  8. Retrospective performance assessment of the draft test guideline 426 on developmental neurotoxicity.

    EPA Science Inventory

    This document was created by an international panel under the auspices of the International Programme on Chemical Safety of the World Health Programme. The purpose and intent of this retrospective performance assessment document is to review the history of the developmen...

  9. Truck parking : an emerging safety hazard to highway users : final report - draft.

    DOT National Transportation Integrated Search

    2017-07-01

    It is recognized nationwide that commercial motor vehicle operators are often unable to find safe and adequate parking to meet hours-of-service (HOS) regulations. This holds true in Oregon, where high-use corridor rest areas and truck stops are exper...

  10. Long term integrity for space station power systems

    NASA Technical Reports Server (NTRS)

    Leckie, F. A.; Marriott, D. L.

    1991-01-01

    A study was made of the High Temperature Design Codes ASME N47, British R5, and the French RCC-MR Rules. It is concluded that all these codes provide a good basis of design for space application. The new British R5 is the most complete since it deals with the problem of defects. The ASME N47 was subjected longer to practical application and scrutiny. A draft code is introduced, and a proposed draft for high temperature design in which attempts were made to identify gaps and improvements is suggested. The design is limited by creep characteristics. In these circumstances, life is strongly affected by the selected value of the factor of safety. The factor of safety of primary loads adopted in the codes is 1.5. Maybe a lower value of 1.25 is permissible for use in space. Long term creep rupture data for HAYNES 188 is deficient and it is suggested that extrapolation methods be investigated.

  11. 78 FR 16483 - Notice of Availability of the Draft Uranium Leasing Program Programmatic Environmental Impact...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-15

    ...The U.S. Department of Energy (DOE) announces the availability of the Draft Uranium Leasing Program Programmatic Environmental Impact Statement (Draft ULP PEIS, DOE/EIS-0472D), for public comment. DOE is also announcing the dates, times, and locations for public hearings to receive comments on the Draft ULP PEIS. DOE has prepared the Draft ULP PEIS pursuant to the National Environmental Policy Act of 1969 (NEPA), the Council on Environmental Quality's (CEQ's) NEPA regulations (40 CFR parts 1500-1508), and DOE's NEPA implementing procedures (10 CFR part 1021) to analyze the reasonably foreseeable potential environmental impacts, including the site-specific impacts, of the range of reasonable alternatives for the management of the ULP. DOE's ULP administers 31 tracts of land covering an aggregate of approximately 25,000 acres (10,000 ha) in Mesa, Montrose, and San Miguel Counties in western Colorado for exploration, mine development, operations, and reclamation of uranium mines. The cooperating agencies on this ULP PEIS are the: U.S. Department of the Interior (DOI), Bureau of Land Management (BLM); U.S. Environmental Protection Agency (EPA); Colorado Department of Transportation; Colorado Division of Reclamation, Mining, and Safety; Colorado Parks and Wildlife ; Mesa County Commission; Montrose County Commission; San Juan County Commission; San Miguel County Board of Commissioners; Pueblo of Acoma Tribe; Pueblo de Cochiti Tribe; Pueblo de Isleta Tribe; Navajo Nation; and Southern Ute Indian Tribe.

  12. Design optimization of hydraulic turbine draft tube based on CFD and DOE method

    NASA Astrophysics Data System (ADS)

    Nam, Mun chol; Dechun, Ba; Xiangji, Yue; Mingri, Jin

    2018-03-01

    In order to improve performance of the hydraulic turbine draft tube in its design process, the optimization for draft tube is performed based on multi-disciplinary collaborative design optimization platform by combining the computation fluid dynamic (CFD) and the design of experiment (DOE) in this paper. The geometrical design variables are considered as the median section in the draft tube and the cross section in its exit diffuser and objective function is to maximize the pressure recovery factor (Cp). Sample matrixes required for the shape optimization of the draft tube are generated by optimal Latin hypercube (OLH) method of the DOE technique and their performances are evaluated through computational fluid dynamic (CFD) numerical simulation. Subsequently the main effect analysis and the sensitivity analysis of the geometrical parameters of the draft tube are accomplished. Then, the design optimization of the geometrical design variables is determined using the response surface method. The optimization result of the draft tube shows a marked performance improvement over the original.

  13. NASA Low Visibility Landing and Surface Operations (LVLASO) Atlanta Demonstration: Surveillance Systems Performance Analysis

    NASA Technical Reports Server (NTRS)

    Cassell, Rick; Evers, Carl; Hicok, Dan; Lee, Derrick

    1999-01-01

    NASA conducted a series of flight experiments at Hartsfield Atlanta International Airport as part of the Low Visibility Landing and Surface Operations (LVLASO) Program. LVLASO is one of the subelements of the NASA Terminal Area Productivity (TAP) Program, which is focused on providing technology and operating procedures for achieving clear-weather airport capacity in instrument-weather conditions, while also improving safety. LVLASO is investigating various technologies to be applied to airport surface operations, including advanced flight deck displays and surveillance systems. The purpose of this report is to document the performance of the surveillance systems tested as part of the LVLASO flight experiment. There were three surveillance sensors tested: primary radar using Airport Surface Detection Equipment (ASDE-3) and the Airport Movement Area Safety System (AMASS), Multilateration using the Airport Surface Target Identification System (ATIDS), and Automatic Dependent Surveillance - Broadcast (ADS-B) operating at 1090 MHz. The performance was compared to the draft requirements of the ICAO Advanced Surface Movement Guidance and Control System (A-SMGCS). Performance parameters evaluated included coverage, position accuracy, and update rate. Each of the sensors was evaluated as a stand alone surveillance system.

  14. 76 FR 78661 - Correction for Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ...-0014] Correction for Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data..., Biological, and Health Data From the Island of Vieques, Puerto Rico.'' This comment period was published as closing on January 11, 2012 in error. The comment period will be open for 90 days and will close March 11...

  15. FORENSIC DNA BANKING LEGISLATION IN DEVELOPING COUNTRIES: PRIVACY AND CONFIDENTIALITY CONCERNS REGARDING A DRAFT FROM TURKISH LEGISLATION.

    PubMed

    Ilgili, Önder; Arda, Berna

    This paper presents and analyses, in terms of privacy and confidentiality, the Turkish Draft Law on National DNA Database prepared in 2004, and concerning the use of DNA analysis for forensic objectives and identity verification in Turkey. After a short introduction including related concepts, we evaluate the draft law and provide articles about confidentiality. The evaluation reminded us of some important topics at international level for the developing countries. As a result, the need for sophisticated legislations about DNA databases, for solutions to issues related to the education of employees, and the technological dependency to other countries emerged as main challenges in terms of confidentiality for the developing countries. As seen in the Turkish Draft Law on National DNA Database, the protection of the fundamental rights and freedoms requires more care during the legislative efforts.

  16. 49 CFR 215.125 - Defective uncoupling device.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

  17. 49 CFR 215.125 - Defective uncoupling device.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

  18. 49 CFR 215.125 - Defective uncoupling device.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

  19. 49 CFR 215.125 - Defective uncoupling device.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

  20. 49 CFR 215.125 - Defective uncoupling device.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

  1. 76 FR 10917 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... in the agency's ``Regulatory Guide'' series. This series was developed to describe and make available... connection assemblies can perform their safety functions during and after a design-basis event. Title 10 of... Reprocessing Plants,'' Criterion III, ``Design Control,'' requires, in part, that test programs used to verify...

  2. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... information (e.g., characterization, adventitious agent safety, process controls, and specifications) for the... Manufacturing Process Assessment of Physiochemical Properties Functional Activities Receptor Binding and... 351(k) application. FDA will also seek OMB approval for this information collection. In addition, this...

  3. Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

    PubMed

    Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

    2017-08-23

    The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

  4. Draft Environmental Statement For Physics and Astronomy Sounding Rocket, Balloon, and Airborne Research Programs

    NASA Technical Reports Server (NTRS)

    1971-01-01

    This document is a draft of an environmental impact statement, evaluating the effect on the environment of the use of sounding rockets, balloons and air borne research programs in studying the atmosphere.

  5. Pre-existing lumbar spine diagnosis as a predictor of outcomes in National Football League athletes.

    PubMed

    Schroeder, Gregory D; Lynch, T Sean; Gibbs, Daniel B; Chow, Ian; LaBelle, Mark; Patel, Alpesh A; Savage, Jason W; Hsu, Wellington K; Nuber, Gordon W

    2015-04-01

    It is currently unknown how pre-existing lumbar spine conditions may affect the medical evaluation, draft status, and subsequent career performance of National Football League (NFL) players. To determine if a pre-existing lumbar diagnosis affects a player's draft status or his performance and longevity in the NFL. Cohort study; Level 3. The investigators evaluated the written medical evaluations and imaging reports of prospective NFL players from a single franchise during the NFL Scouting Combine from 2003 to 2011. Players with a reported lumbar spine diagnosis and with appropriate imaging were included in this study. Athletes were then matched to control draftees without a lumbar spine diagnosis by age, position, year, and round drafted. Career statistics and performance scores were calculated. Of a total of 2965 athletes evaluated, 414 were identified as having a pre-existing lumbar spine diagnosis. Players without a lumbar spine diagnosis were more likely to be drafted than were those with a diagnosis (80.2% vs. 61.1%, respectively, P < .001). Drafted athletes with pre-existing lumbar spine injuries had a decrease in the number of years played compared with the matched control group (4.0 vs. 4.3 years, respectively, P = .001), games played (46.5 vs. 50.8, respectively, P = .0001), and games started (28.1 vs. 30.6, respectively, P = .02) but not performance score (1.4 vs. 1.8, respectively, P = .13). Compared with controls, players were less likely to be drafted if they had been diagnosed with spondylosis (62.37% vs. 78.55%), a lumbar herniated disc (60.27% vs. 78.43%), or spondylolysis with or without spondylolisthesis (64.44% vs. 78.15%) (P < .001 for all), but there was no appreciable effect on career performance; however, the diagnosis of spondylolysis was associated with a decrease in career longevity (P < .05). Notably, 2 athletes who had undergone posterior lateral lumbar fusion were drafted. One played in 125 games, and the other is still active and has played in 108 games. The data in this study suggest that athletes with pre-existing lumbar spine conditions were less likely to be drafted and that the diagnosis is associated with a decrease in career longevity but not performance. Players with lumbar fusion have achieved successful careers in the NFL. © 2015 The Author(s).

  6. USDA’s Corner

    USDA-ARS?s Scientific Manuscript database

    The 17a-methyltestosterone Target Animal Safety study with tilapia was completed early this summer and we are finalizing the QA audit with an ‘in-life study’ report. We are also assisting AADAP with compiling a draft of the Final Study Report for FDA. We will present findings with respect to acute...

  7. 78 FR 4150 - Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-18

    ...; NIOSH-134-B] Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance AGENCY: National... Nanotechnology Strategic Plan for Research and Guidance. SUMMARY: The National Institute for Occupational Safety... NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the...

  8. Driver distraction analysis on naturalistic heavy vehicle data : Task 2: Analysis of sleeper berth data for distraction events - Draft final report

    DOT National Transportation Integrated Search

    2001-10-04

    Data from 41 long-haul truck drivers were collected and analyzed for the Federal Motor Carriers Safety Administration (FMCSA) sponsored project entitled, Impact of Sleeper Berth Usage on Driver Fatigue (Dingus et al., 2001). This data was colle...

  9. Targeted evidence report : cochlear implants and commercial motor vehicle driver safety : draft, October 29, 2010, revised January 14, 2011.

    DOT National Transportation Integrated Search

    2011-01-14

    This report was prepared by MANILA Consulting Group, Inc. under Contract No. GS-10F-0177N; Order No. DTMC75-10-F-00013, entitled Medical Programs Research and Analysis Panels Project, with the Department of Transportations Federal Motor Carrier...

  10. 77 FR 77117 - Proposed Revision 0 on Access Authorization-Operational Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ...--Operational Program AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision... public comment on NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for... seeks comments on the new Section 13.6.4 of the Standard Review Plan (SRP) concerning implementation of...

  11. 77 FR 50720 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Test Documentation for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1207, ``Test Documentation for Digital... practices for test documentation for software and computer systems as described in the Institute of...

  12. 78 FR 2868 - Draft Environmental Assessment for Rulemaking To Establish Minimum Sound Requirements for Hybrid...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... require hybrid and electric passenger cars, light trucks, medium and heavy duty trucks and buses, low... Sound Requirements for Hybrid and Electric Vehicles AGENCY: National Highway Traffic Safety... minimum sound requirements for hybrid and electric vehicles. DATES: Comments must be received on or before...

  13. Safety and fitness electronic records system (SAFER) : draft master test plan

    DOT National Transportation Integrated Search

    1995-12-31

    The purpose of this plan is to establish a formal set of guidelines and activities to be : adhered to and performed by JHU/APL and the developer to ensure that the SAFER System has been tested successfully and is fully compliant with the SAFER System...

  14. 77 FR 12818 - Intent To Prepare a Draft Supplemental Environmental Impact Statement for the Proposed Rio Grande...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ..., floodplain development, water quality, ecological resources, endangered species, wildlife refuge objectives, social welfare, human safety, cultural resources, and aesthetic qualities. Development and implementation... risk management study along the Rio Grande from San Acacia downstream to San Marcial in Socorro County...

  15. 78 FR 36698 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three...

  16. 78 FR 48504 - Proposed Revisions to Maintenance Rule Standard Review Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... Review Plan AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision... Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,'' Section 17... and Management System (ADAMS): You may access publicly available documents online in the NRC Library...

  17. 78 FR 41434 - Proposed Revisions to Design of Structures, Components, Equipment and Systems

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ..., Components, Equipment and Systems AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft... Systems, Piping Components and their Associated Supports,'' of NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition.'' DATES: Submit comments by...

  18. 49 CFR 231.16 - Steam locomotives used in switching service.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... clearance. No part of locomotive or tender except draft rigging, coupler and attachments, safety chains, buffer block, footboard, brake pipe, signal pipe, steam-heat pipe or arms of uncoupling lever shall... with horn of coupler against buffer block or end sill. (h) Couplers. Locomotives shall be equipped with...

  19. 49 CFR 231.16 - Steam locomotives used in switching service.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... clearance. No part of locomotive or tender except draft rigging, coupler and attachments, safety chains, buffer block, footboard, brake pipe, signal pipe, steam-heat pipe or arms of uncoupling lever shall... with horn of coupler against buffer block or end sill. (h) Couplers. Locomotives shall be equipped with...

  20. 49 CFR 231.16 - Steam locomotives used in switching service.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... clearance. No part of locomotive or tender except draft rigging, coupler and attachments, safety chains, buffer block, footboard, brake pipe, signal pipe, steam-heat pipe or arms of uncoupling lever shall... with horn of coupler against buffer block or end sill. (h) Couplers. Locomotives shall be equipped with...

  1. 49 CFR 231.16 - Steam locomotives used in switching service.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... clearance. No part of locomotive or tender except draft rigging, coupler and attachments, safety chains, buffer block, footboard, brake pipe, signal pipe, steam-heat pipe or arms of uncoupling lever shall... with horn of coupler against buffer block or end sill. (h) Couplers. Locomotives shall be equipped with...

  2. 49 CFR 231.16 - Steam locomotives used in switching service.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... clearance. No part of locomotive or tender except draft rigging, coupler and attachments, safety chains, buffer block, footboard, brake pipe, signal pipe, steam-heat pipe or arms of uncoupling lever shall... with horn of coupler against buffer block or end sill. (h) Couplers. Locomotives shall be equipped with...

  3. Integrated therapy safety management system

    PubMed Central

    Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

    2013-01-01

    Aims The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an ‘integrated therapy safety management’ is drafted. This concept could serve as a basis to improve resilience. Methods The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for ‘integrated therapy safety management’. The concept is applied by way of example for the ‘medication process’ to demonstrate its practical implementation. Results The ‘integrated therapy safety management’ is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of ‘bridge managers’. ‘Bridge managers’ anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the ‘bridge managers’ and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. Conclusions The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. PMID:24007448

  4. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions.

  5. Influence of the Runner Gap on the Flow Field in the Draft Tube of a Low Head Turbine

    NASA Astrophysics Data System (ADS)

    Junginger, Bernd; Riedelbauch, Stefan

    2016-11-01

    The gap flow of axial turbines is usually neglected in the design process of hydraulic machines, although it can lead to a stabilization of the draft tube flow. Though, this negligence of the gap can falsify the flow field in the draft tube. Presented in this paper are simulations of an axial propeller turbine operated at Δγ = Δγ BEP with Q > Qbep . Simulations of four gap sizes, using a mesh with about 15 million elements for the entire machine, are performed. Additionally, two turbulence models are applied, the k-ω-SST and the SAS-SST model. At the evaluated operating point a full load vortex develops. Depending on the turbulence model the developing vortex rope can either arise from the hub in a straight shape or in a shape resembling a corkscrew. Integral quantities such as head and torque are compared with experimental model test results performed in the laboratory of the Institute. Flow field simulation results are evaluated for different gap widths. Furthermore, the impact of the gap flow respectively the gap size can be observed in velocity profiles evaluated at different positions downstream the runner until to the end of the draft tube cone. Moreover, the pressure signals recorded at the beginning of the draft tube cone are also affected by the gap flow.

  6. Ulcerative colitis outpatient management: development and evaluation of tools to support primary care practitioners.

    PubMed

    Bennett, A L; Buckton, S; Lawrance, I; Leong, R W; Moore, G; Andrews, J M

    2015-12-01

    Current models of care for ulcerative colitis (UC) across healthcare systems are inconsistent with a paucity of existing guidelines or supportive tools for outpatient management. This study aimed to produce and evaluate evidence-based outpatient management tools for UC to guide primary care practitioners and patients in clinical decision-making. Three tools were developed after identifying current gaps in the provision of healthcare services for patients with UC at a Clinical Insights Meeting in 2013. Draft designs were further refined through consultation and consolidation of feedback by the steering committee. Final drafts were developed following feasibility testing in three key stakeholder groups (gastroenterologists, general practitioners and patients) by questionnaire. The tools were officially launched into mainstream use in Australia in 2014. Three quarters of all respondents liked the layout and content of each tool. Minimal safety concerns were aired and those, along with pieces of information that were felt to be omitted, that were reviewed by the steering committee and incorporated into the final documents. The majority (over 80%) of respondents felt that the tools would be useful and would improve outpatient management of UC. Evidence-based outpatient clinical management tools for UC can be developed. The concept and end-product have been well received by all stakeholder groups. These tools should support non-specialist clinicians to optimise UC management and empower patients by facilitating them to safely self-manage and identify when medical support is needed. © 2015 Royal Australasian College of Physicians.

  7. Draft genome sequence of Xylella fastidiosa subsp. fastidiosa strain Stag’s Leap

    USDA-ARS?s Scientific Manuscript database

    Xylella fastidiosa subsp. fastidiosa causes Pierce’s disease of grapevine. Presented here is the draft genome sequence of the Stag’s Leap strain, previously used in pathogenicity/virulence assays to evaluate grapevine germplasm bearing Pierce’s disease....

  8. New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation.

    PubMed

    Chimonas, Susan; Rothman, David J

    2005-01-01

    In October 2002 the federal government issued a draft "Compliance Program Guidance for Pharmaceutical Manufacturers." The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and research grants, consultantcies, and gifts. Medical organizations and drug manufacturers proposed major revisions to the draft, arguing that current practices were in everyone's best interest. To evaluate the impact of their responses, we compare the draft, the changes requested by industry and organized medicine, and the final Guidance document (issued in April 2003). We also explore the implications--some intended, others unanticipated--of the final document.

  9. Flight Simulation Model Exchange. Volume 1

    NASA Technical Reports Server (NTRS)

    Murri, Daniel G.; Jackson, E. Bruce

    2011-01-01

    The NASA Engineering and Safety Center Review Board sponsored an assessment of the draft Standard, Flight Dynamics Model Exchange Standard, BSR/ANSI-S-119-201x (S-119) that was conducted by simulation and guidance, navigation, and control engineers from several NASA Centers. The assessment team reviewed the conventions and formats spelled out in the draft Standard and the actual implementation of two example aerodynamic models (a subsonic F-16 and the HL-20 lifting body) encoded in the Extensible Markup Language grammar. During the implementation, the team kept records of lessons learned and provided feedback to the American Institute of Aeronautics and Astronautics Modeling and Simulation Technical Committee representative. This document contains the results of the assessment.

  10. Flight Simulation Model Exchange. Volume 2; Appendices

    NASA Technical Reports Server (NTRS)

    Murri, Daniel G.; Jackson, E. Bruce

    2011-01-01

    The NASA Engineering and Safety Center Review Board sponsored an assessment of the draft Standard, Flight Dynamics Model Exchange Standard, BSR/ANSI-S-119-201x (S-119) that was conducted by simulation and guidance, navigation, and control engineers from several NASA Centers. The assessment team reviewed the conventions and formats spelled out in the draft Standard and the actual implementation of two example aerodynamic models (a subsonic F-16 and the HL-20 lifting body) encoded in the Extensible Markup Language grammar. During the implementation, the team kept records of lessons learned and provided feedback to the American Institute of Aeronautics and Astronautics Modeling and Simulation Technical Committee representative. This document contains the appendices to the main report.

  11. Six years after the NRC review of EPA's Draft IRIS Toxicological Review of Formaldehyde: Regulatory implications of new science in evaluating formaldehyde leukemogenicity.

    PubMed

    Mundt, Kenneth A; Gentry, P Robinan; Dell, Linda D; Rodricks, Joseph V; Boffetta, Paolo

    2018-02-01

    Shortly after the International Agency for Research on Cancer (IARC) determined that formaldehyde causes leukemia, the United States Environmental Protection Agency (EPA) released its Draft IRIS Toxicological Review of Formaldehyde ("Draft IRIS Assessment"), also concluding that formaldehyde causes leukemia. Peer review of the Draft IRIS Assessment by a National Academy of Science committee noted that "causal determinations are not supported by the narrative provided in the draft" (NRC 2011). They offered recommendations for improving the Draft IRIS assessment and identified several important research gaps. Over the six years since the NRC peer review, significant new science has been published. We identify and summarize key recommendations made by NRC and map them to this new science, including extended analysis of epidemiological studies, updates of earlier occupational cohort studies, toxicological experiments using a sensitive mouse strain, mechanistic studies examining the role of exogenous versus endogenous formaldehyde in bone marrow, and several critical reviews. With few exceptions, new findings are consistently negative, and integration of all available evidence challenges the earlier conclusions that formaldehyde causes leukemia. Given formaldehyde's commercial importance, environmental ubiquity and endogenous production, accurate hazard classification and risk evaluation of whether exposure to formaldehyde from occupational, residential and consumer products causes leukemia are critical. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  12. [European Blood Alliance (EBA) and EuroNet TMS: what challenges for the transfusion of tomorrow?].

    PubMed

    Folléa, G; de Wit, J; Rouger, P

    2011-04-01

    The primary mission of the European Blood Alliance (EBA) is to contribute to the safety and efficiency of the supply of blood products, cells and tissues, in developing an active network of blood establishments in Europe (25 countries). Its strategic objectives are to improve performance (through working groups and projects funded by the European Union), to engage in regulatory affairs (particularly at the European Commission level) to promote best practices and to facilitate a network to collect and share knowledge and experiences. The main objective of EuroNet TMS, combining the blood scientific societies from more than 30 countries in Europe, is to update and publish regularly, intended for policymakers, a White Book on the transfusion chain from donor to patient and probable or possible changes in the coming 5 years. Since 2008, EBA and EuroNet TMS actively collaborate on the drafting of the 2nd edition to be published in 2011. The two presidents jointly drafted the final chapter outlining the major issues of transfusion for tomorrow, summarized thereafter. Transfusion will still be useful for a long time and for reasons of safety and ethics the voluntary and unpaid donations, with non-profit blood establishments, will remain, the cornerstone of the supply of blood products. This renders crucial the continuous improvement of donor management and optimal blood use. On the regulatory side, after 5 years of implementation, EU directives must be independently evaluated and the Blood Guide of the Council of Europe should gradually become a regulatory standard. Finally, if a competition should be introduced for the blood products, it should be strictly regulated to prevent any threat to the security of their supply and quality for patients. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  13. 75 FR 2154 - Central Utah Project Completion Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ..., Office of the Assistant Secretary-- Water and Science. ACTION: Notice of Availability, Draft Environmental Assessment (Draft EA), Wasatch County Water Efficiency Project Recycled Water Project. SUMMARY... of the Interior and the Central Utah Water Conservancy District are evaluating the impacts of the...

  14. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised August 2014 External Review Draft) (SAB Review Draft)

    EPA Science Inventory

    EPA is seeking peer review of the scientific basis supporting the human health hazard and dose-response assessment of ethylene oxide (cancer) that will appear in the Integrated Risk Information System (IRIS) database.

  15. Development of an effective risk management system in a teaching hospital.

    PubMed

    Adibi, Hossein; Khalesi, Nader; Ravaghi, Hamid; Jafari, Mahdi; Jeddian, Ali Reza

    2012-09-21

    Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context. WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches. The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The "non-punitive responses to error" had lowest positive score with 21.2 percent. It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

  16. Drafting. Competency Based Curriculum.

    ERIC Educational Resources Information Center

    Everly, Al; And Others

    This competency based drafting curriculum is presented in seven specialization sections with units in each section containing a competency statement, performance objective, learning activities, evaluation, and quiz or problem sheets. Some units also contain answer sheets and/or handout sheets. Sections and number of units presented are (1) basic…

  17. 10 CFR 960.3-2-2-4 - The environmental assessment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... the site-characterization activities at the site on public health and safety and the environment; a discussion of alternative activities related to site characterization that may be taken to avoid such impact; and an assessment of the regional and local impacts of locating a repository at the site. The draft...

  18. 49 CFR 215.123 - Defective couplers.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.123 Defective couplers. A railroad may not place or continue in service a car, if— (a) The car is... automatically with the adjacent car; (b) The car has a coupler that has a crack in the highly stressed junction...

  19. 49 CFR 215.123 - Defective couplers.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.123 Defective couplers. A railroad may not place or continue in service a car, if— (a) The car is... automatically with the adjacent car; (b) The car has a coupler that has a crack in the highly stressed junction...

  20. 49 CFR 215.123 - Defective couplers.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.123 Defective couplers. A railroad may not place or continue in service a car, if— (a) The car is... automatically with the adjacent car; (b) The car has a coupler that has a crack in the highly stressed junction...

  1. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... process includes submitting a time and extent application (TEA) to determine whether a condition is..., submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled ``Time...

  2. Program Multi - A Multi-purpose Program for Computing and Graphing Roots and Values for Any Real Function -- Users/Programmers Manual

    DOT National Transportation Integrated Search

    1976-05-01

    As part of its activity under the Rail Equipment Safety Project, computer programs for track/train dynamics analysis are being developed and modified. As part of this effort, derailment behavior of trains negotiating curves under buff or draft has be...

  3. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and... devices that have established safety and effectiveness profiles and for which it believes 510(k) review is... 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the...

  4. 78 FR 46588 - Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... Vaccine Safety Monitoring and Post-Marketing Surveillance 4. Building Global Immunization Research and... activities not represented in the report where HHS efforts can offer a comparative advantage or where HHS... global immunization efforts and the role of HHS in enhancing those efforts. Examples of potential...

  5. 77 FR 54875 - Codex Alimentarius Commission: Meeting of the Codex Committee on Fish and Fishery Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-06

    ... final product requirements) Proposed Food Additive Provisions in Standards for Fish and Fishery Products... (held at Step 7) Section 4 Food Additives Draft Standard for Quick Frozen Scallop Adductor Muscle Meat... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2012-0035] Codex...

  6. 75 FR 7615 - Towing Safety Advisory Committee; Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... will meet in New Orleans, LA. The Committee will also discuss various issues relating to shallow-draft... March 2, 2010. ADDRESSES: The meetings will be held at the New Orleans Marriott Metairie at Lakeway in New Orleans, LA; 3838 N. Causeway Boulevard, Metairie, LA 70002; Phone: 1-504-836-5253, Toll-free: 1...

  7. 76 FR 19978 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... Exposure Survey AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The U.S. Consumer....regulations.gov . A copy of the draft survey is available at http://www.regulations.gov under Docket No. CPSC... OMB for review and clearance: Durable Nursery Products Exposure Survey. On August 14, 2008, the...

  8. 78 FR 8118 - Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    ... Herbert Hoover Dike Major Rehabilitation Project, Martin and Palm Beach Counties AGENCY: Department of the... Supplemental Environmental Impact Statement (SEIS) for Reach 1A on the Herbert Hoover Dike (HHD) Major... required for safety modifications to dams. FOR FURTHER INFORMATION CONTACT: Questions may be forwarded to...

  9. 75 FR 62417 - Draft Environmental Impact Statement for the Proposed Manzanita Band of Kumeyaay Indians Fee-to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ...,000 square feet of food/beverage and retail components; a 38,660-square-foot entertainment venue; and..., Federal review (by the National Indian Gaming Commission) of the development and management contract, and... Division of Environmental, Cultural Resources Management and Safety, at the telephone number provided in...

  10. An Approach to Using Toxicogenomic Data in US EPA Human ...

    EPA Pesticide Factsheets

    This draft report is a description of an approach to evaluate genomic data for use in risk assessment and a case study to illustrate the approach. The dibutyl phthalate (DBP) case study example focuses on male reproductive developmental effects and the qualitative application of the available genomic data. The case study presented in this draft document is a separate activity from any of the ongoing IRIS human health assessments for the phthalates. This draft report is a description of an approach to evaluate genomic data for use in risk assessment and a case study to illustrate the approach. The dibutyl phthalate (DBP) case study example focuses on male reproductive developmental effects and the qualitative application of the available genomic data.

  11. Assessment of Risk Evaluation and Mitigation Strategies in Oncology: Summary of the Oncology Risk Evaluation and Mitigation Strategies Workshop

    PubMed Central

    Frame, James N.; Jacobson, Joseph O.; Vogel, Wendy H.; Griffith, Niesha; Wariabharaj, Darshan; Garg, Rekha; Zon, Robin; Stephens, Cyntha L.; Bialecki, Alison M.; Bruinooge, Suanna S.; Allen, Steven L.

    2013-01-01

    To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder presentations and topical panel discussions addressed REMS program development, implementation processes, and practice experiences, as well as oncology drug safety processes. A draft REMS decision tool prepared by the ASCO REMS Steering Committee was presented for group discussion with facilitated, goal-oriented feedback. The workshop identified several unintended consequences resulting from current oncology REMS: (1) the release of personal health information to drug sponsors as a condition for gaining access to a needed drug; (2) risk information that is not tailored—and therefore not accessible—to all literacy levels; (3) exclusive focus on drug risk, thereby affecting patient-provider treatment discussion; (4) REMS elements that do not consider existing, widely practiced oncology safety standards, professional training, and experience; and (5) administrative burdens that divert the health care team from direct patient care activities and, in some cases, could limit patient access to important therapies. Increased provider and professional society participation should form the basis of ongoing and future REMS standardization discussions with the FDA to work toward overall improvement of risk communication. PMID:23814522

  12. Performance Evaluation of Kitchen Exhaust Draft Hoods.

    DTIC Science & Technology

    1980-03-01

    1-ACI827 JOHNS - MANVILLE SALES CORP DENVER CO RESEARCH AND DEV-ETC F/e 13/1 PERFORMANCE EVALUATION OF KITCHEN EXHAUST DRAFT HOOOS. (U) MAR 80 P 8...ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT PROJECT. TASK AREA a WOPK UNIT NUMOERS Johns - Manville Sales Corper a, t Research & Development Center /0004...P. B. SHEPHERD, R. H. NEISEL JOHNS - MANVILLE SALES CORPORATION RESEARCH & DEVELOPMENT CENTER KEN-CARYL RANCH, DENVER, COLORADO 80217 MARCH 1980 FINAL

  13. Contributions to Integral Nuclear Data in ICSBEP and IRPhEP since ND 2013

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Bess, John D.; Briggs, J. Blair; Gulliford, Jim

    2016-09-01

    The status of the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and the International Reactor Physics Experiment Evaluation Project (IRPhEP) was last discussed directly with the international nuclear data community at ND2013. Since ND2013, integral benchmark data that are available for nuclear data testing has continued to increase. The status of the international benchmark efforts and the latest contributions to integral nuclear data for testing is discussed. Select benchmark configurations that have been added to the ICSBEP and IRPhEP Handbooks since ND2013 are highlighted. The 2015 edition of the ICSBEP Handbook now contains 567 evaluations with benchmark specifications for 4,874more » critical, near-critical, or subcritical configurations, 31 criticality alarm placement/shielding configuration with multiple dose points apiece, and 207 configurations that have been categorized as fundamental physics measurements that are relevant to criticality safety applications. The 2015 edition of the IRPhEP Handbook contains data from 143 different experimental series that were performed at 50 different nuclear facilities. Currently 139 of the 143 evaluations are published as approved benchmarks with the remaining four evaluations published in draft format only. Measurements found in the IRPhEP Handbook include criticality, buckling and extrapolation length, spectral characteristics, reactivity effects, reactivity coefficients, kinetics, reaction-rate distributions, power distributions, isotopic compositions, and/or other miscellaneous types of measurements for various types of reactor systems. Annual technical review meetings for both projects were held in April 2016; additional approved benchmark evaluations will be included in the 2016 editions of these handbooks.« less

  14. EVALUATION OF THE POTENTIAL CARCINOGENICITY OF ELECTROMAGNETIC FIELDS (EXTERNAL REVIEW DRAFT)

    EPA Science Inventory

    The U.S. Environmental Protection Agency (EPA or Agency) is posting on this web site a draft document related to the potential adverse human health effects resulting from exposure to electromagnetic fields (EMF). This document was never finalized after EPA activities were discon...

  15. Contribution of draft cattle to rural livelihoods in a district of southeastern Uganda endemic for bovine parasitic diseases: an economic evaluation.

    PubMed

    Okello, Walter O; Muhanguzi, Dennis; MacLeod, Ewan T; Welburn, Susan C; Waiswa, Charles; Shaw, Alexandra P

    2015-11-05

    A study was conducted in Tororo District in eastern Uganda to assess the socio-economic contribution of draft cattle to rural livelihoods. The aim of the study was to empirically quantify the economic value of draft cattle thus contributing to understanding the impact of endemic parasitic diseases of cattle on livestock productivity and subsequently household income, labor and food security. A total of 205 draft cattle keeping households (n = 205) were randomly selected and structured household questionnaires were administered, focusing on work oxen use, productivity, inputs and outputs. The data obtained was analyzed using standard statistical methods and used to calculate the gross margin from the draft cattle enterprise. Secondary data were obtained from focus group discussions and key informant interviews and these were analyzed using Bayesian methods. The study showed that, apart from being labor saving, the use of animal traction is highly profitable with the gross margin per year from the use of draft cattle amounting to 245 United States dollars per work oxen owning household. The cash obtained from hiring out draft animals was equivalent to nearly a quarter of the average local household's monetary receipts. It also revealed that endemic bovine parasitic diseases such as trypanosomiasis and tick-borne diseases reduced draft cattle output by 20.9 % and potential household income from the use of draft oxen by 32.2 %. The presence of endemic cattle diseases in rural Uganda is adversely affecting the productivity of draft cattle, which in turn affects household income, labor and ultimately food security. This study highlights the contribution of draft cattle to rural livelihoods, thus increasing the expected impact of cost-effective control strategies of endemic production limiting livestock diseases in Uganda.

  16. [Blood transfusion in the Democratic Republic of Congo: efforts and challenges].

    PubMed

    Kabinda Maotela, J; Ramazani, S Y; Misingi, P; Dramaix-Wilmet, M

    2015-01-01

    The authors trace the history of blood transfusion in the Democratic Republic of Congo, as inherited through the colonial organization of the health system. The current configuration of transfusion system begins with the drafting of the national blood transfusion policy and the establishment of a national technical office within the Ministry of Health to coordinate transfusion activities and of its agents in each province. Despite countless difficulties, several positive points were noted. These involve essentially the drafting of all the necessary documents and standards and the integration of the blood safety system into the country's health system. Initially, the blood transfusion system applied a vertical approach, but with the reform of the country's health system, the performance of blood safety became transversal. In the 12 years from 2001 to 2012, it mobilized 112,882 volunteer blood donors; more than 80% of blood products were checked for safety and covered all blood needs; and 81,806 HIV infections were avoided by routine testing of blood products. During the same period, 7560 people were trained in blood transfusion. The prevalence of viral markers among donors has diminished sharply. Thus, HIV prevalence decreased from 4.7% to 2.1% between 2001 and 2012 that of hepatitis B dropped from 7.1% to 3.5% during the same period, and hepatitis C from 11.8% to 2.3% from 2004 to 2012. Despite this performance, enormous efforts are still required, for the organization of blood safety monitoring, the establishment of a safe supply of reagents and supplies, for sustaining the dynamics of voluntary associations of blood donors, and finally for providing stable funding for these blood safety activities.

  17. Draft genome sequence and annotation of Lactobacillus acetotolerans BM-LA14527, a beer-spoilage bacteria.

    PubMed

    Liu, Junyan; Li, Lin; Peters, Brian M; Li, Bing; Deng, Yang; Xu, Zhenbo; Shirtliff, Mark E

    2016-09-01

    Lactobacillus acetotolerans is a hard-to-culture beer-spoilage bacterium capable of entering into the viable putative nonculturable (VPNC) state. As part of an initial strategy to investigate the phenotypic behavior of L. acetotolerans, draft genome sequencing was performed. Results demonstrated a total of 1824 predicted annotated genes, with several potential VPNC- and beer-spoilage-associated genes identified. Importantly, this is the first genome sequence of L. acetotolerans as beer-spoilage bacteria and it may aid in further analysis of L. acetotolerans and other beer-spoilage bacteria, with direct implications for food safety control in the beer brewing industry. © FEMS 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. Light transport and general aviation aircraft icing research requirements

    NASA Technical Reports Server (NTRS)

    Breeze, R. K.; Clark, G. M.

    1981-01-01

    A short term and a long term icing research and technology program plan was drafted for NASA LeRC based on 33 separate research items. The specific items listed resulted from a comprehensive literature search, organized and assisted by a computer management file and an industry/Government agency survey. Assessment of the current facilities and icing technology was accomplished by presenting summaries of ice sensitive components and protection methods; and assessments of penalty evaluation, the experimental data base, ice accretion prediction methods, research facilities, new protection methods, ice protection requirements, and icing instrumentation. The intent of the research plan was to determine what icing research NASA LeRC must do or sponsor to ultimately provide for increased utilization and safety of light transport and general aviation aircraft.

  19. Updated Draft Protocol for the Evaluation of Bactericidal Activity of Hard, Non-porous Copper Containing Surface Products

    EPA Pesticide Factsheets

    This document describes the updated draft testing protocol recommended by the EPA to support the registration of copper-containing surface products (such as door knobs, or other items that are not intended for food contact) that bear sanitizer claims.

  20. IRIS Toxicological Review and Summary Documents for Vinyl Chloride (External Review Draft)

    EPA Science Inventory

    The Draft Toxicological Review was developed to evaluate both the cancer and non cancer human health risks from environmental exposure to vinyl chloride. A reference concentration (RfC), and a reference dose (RfD) were developed based upon induction of liver cell polymorphism in ...

  1. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised July 2013 External Review Draft) (Public Comment Draft)

    EPA Science Inventory

    EPA is initiating a public comment period prior to peer review of the scientific basis supporting the human health hazard and dose-response assessment of ethylene oxide (cancer) that will appear in the Integrated Risk Information System (IRIS) database.

  2. 77 FR 5797 - Draft Toxicological Review of Vanadium Pentoxide: In Support of Summary Information on the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

    ... Office of Research and Development. EPA is releasing this draft assessment for the purposes of public... health assessment program that evaluates quantitative and qualitative risk information on effects that..., EPA provides the highest quality science- based human health assessments to support the Agency's...

  3. 75 FR 18504 - International Cooperation on Harmonisation of Technical Requirements for Registration of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... Products (VICH). This draft VICH guidance document is intended to provide study design recommendations... Products; Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal...

  4. Regulatory concerns in the development of biologic-biomaterial combinations. United States Food and Drug Administration.

    PubMed

    Chapekar, M S

    1996-01-01

    Several biologic-biomaterial combinations are currently under development in an attempt to modulate tissue or organ function in patients. The FDA regulations on combination products and the intercenter agreements among the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drugs Evaluation and Research (CDER) provide further guidance on center jurisdiction of combination products and other products where there are jurisdictional concerns. The biological component of biologic-biomaterial combinations raises a number of issues that relate to the safety and bioactivity of the final product. For example, transmission of adventitious agents to patients via somatic cells, tissue, or cell-derived products is a major safety concern as are in vivo inflammatory responses elicited by the biomaterial component. CBER has drafted a number of "Points to Consider" documents to provide further guidance in the development of biological products. The intent of this article is to provide the highlights of the FDA regulations for combination products and the intercenter agreement between CBER and CDRH delineating the responsibilities of each center for medical device activities. In addition, the article focuses on the CBER's concerns related to the development of somatic cell-biomaterial combinations for therapeutic use.

  5. Lumbar Spine Injury/Pathology as a Predictor of Outcomes in National Football League Athletes

    PubMed Central

    Lynch, Thomas Sean; Schroeder, Greg; Gibbs, Daniel; Chow, Ian; LaBelle, Mark; Savage, Jason W.; Patel, Alpesh; Hsu, Wellington; Nuber, Gordon W.

    2014-01-01

    Objectives: The purpose of this study is to determine if a pre-existing lumbar diagnosis such as spondylosis, a herniated lumbar disc, or spondylolysis affects a football player’s draft status or his performance and longevity in the NFL. Methods: The written medical evaluations and imaging reports of prospective professional American football athletes from 2003-2011 from one NFL franchise during the NFL combine (annual college football player evaluation prior to the NFL draft) were compiled and evaluated. All players were evaluated for a pre-existing lumbar diagnosis which were compiled from previous injury/medical records including radiographic imaging reports. Those players with a lumbar spine diagnosis and with appropriate radiograph, MRI and CT imaging were included in this study. These athletes were then matched by age, position, year, and round drafted to control draftees without a lumbar spine diagnosis. Career statistics were compiled including length of play and number of games started. Additionally, a previously established “Performance Score” was calculated for all players excluding offensive linemen. The continuous variables of each cohort were compared using a two-sided (tailed) Student’s t-test for normally distributed data. A chi-squared analysis was performed to analyze the categorical data. Statistical significance was accepted with a p < 0.05. Results: Out of a total of 2,965 athletes evaluated from the NFL combine, 414 players were identified with a pre-existing lumbar spine diagnosis. Athletes who attended the NFL combine without a lumbar spine diagnosis were significantly more likely to be drafted than those with one (74% vs. 61% respectively, p < 0.01). There was no difference between the investigational and control group with regard to round drafted, age, year drafted, or position. Overall, athletes with a lumbar spine injury compared to the control group had no difference in the number of years played (4.0 vs. 4.3 years, respectively, p = 0.13), games played (46.5 vs. 50.7, respectively, p = 0.15), games started (28.1 vs. 30.6, respectively, p = 0.39) or performance score (1.4 vs. 1.8, respectively, p = 0.3) (Figure 1). Conclusion: The data in this study suggests that a pre-existing lumbar spine diagnosis was associated with a significantly lower draft status for NFL athletes. However, the data in our study suggests that such a diagnosis did not affect a player’s career longevity or performance. Further study will be required to determine the individual effects of specific conditions on performance.

  6. Training infection control and hospital hygiene professionals in Europe, 2010: agreed core competencies among 33 European countries.

    PubMed

    Brusaferro, S; Cookson, B; Kalenic, S; Cooper, T; Fabry, J; Gallagher, R; Hartemann, P; Mannerquist, K; Popp, W; Privitera, G; Ruef, C; Viale, P; Coiz, F; Fabbro, E; Suetens, C; Varela Santos, C

    2014-12-11

    The harmonisation of training programmes for infection control and hospital hygiene (IC/HH) professionals in Europe is a requirement of the Council recommendation on patient safety. The European Centre for Disease Prevention and Control commissioned the 'Training Infection Control in Europe' project to develop a consensus on core competencies for IC/HH professionals in the European Union (EU). Core competencies were drafted on the basis of the Improving Patient Safety in Europe (IPSE) project's core curriculum (CC), evaluated by questionnaire and approved by National Representatives (NRs) for IC/HH training. NRs also re-assessed the status of IC/HH training in European countries in 2010 in comparison with the situation before the IPSE CC in 2006. The IPSE CC had been used to develop or update 28 of 51 IC/HH courses. Only 10 of 33 countries offered training and qualification for IC/HH doctors and nurses. The proposed core competencies are structured in four areas and 16 professional tasks at junior and senior level. They form a reference for standardisation of IC/HH professional competencies and support recognition of training initiatives.

  7. Recommendations to Improve Employee Thermal Comfort When Working in 40°F Refrigerated Cold Rooms.

    PubMed

    Ceballos, Diana; Mead, Kenneth; Ramsey, Jessica

    2015-01-01

    Cold rooms are commonly used for food storage and preparation, and are usually kept around 40°F following food safety guidelines. Some food preparation employees may spend 8 or more hours inside cold rooms. These employees may not be aware of the risks associated with mildly cold temperatures, dampness, and limited ventilation. We performed an evaluation of cold rooms at an airline catering facility because of concerns with exposure to cold temperatures. We spoke with and observed employees in two cold rooms, reviewed daily temperature logs, evaluated employee's physical activity, work/rest schedule, and protective clothing. We measured temperature, percent relative humidity, and air velocities at different work stations inside the cold rooms. We concluded that thermal comfort concerns perceived by cold room employees may have been the result of air drafts at their workstations, insufficient use of personal protective equipment due to dexterity concerns, work practices, and lack of knowledge about good health and safety practices in cold rooms. These moderately cold work conditions with low air velocities are not well covered in current occupational health and safety guidelines, and wind chill calculations do not apply. We provide practical recommendations to improve thermal comfort of cold room employees. Engineering control recommendations include the redesigning of air deflectors and installing of suspended baffles. Administrative controls include the changing out of wet clothing, providing hand warmers outside of cold rooms, and educating employees on cold stress. We also recommended providing more options on personal protective equipment. However, there is a need for guidelines and educational materials tailored to employees in moderately cold environments to improve thermal comfort and minimize health and safety problems.

  8. Recommendations to Improve Employee Thermal Comfort When Working in 40°F Refrigerated Cold Rooms

    PubMed Central

    Ceballos, Diana; Mead, Kenneth; Ramsey, Jessica

    2015-01-01

    Cold rooms are commonly used for food storage and preparation, and are usually kept around 40°F following food safety guidelines. Some food preparation employees may spend 8 or more hours inside cold rooms. These employees may not be aware of the risks associated with mildly cold temperatures, dampness, and limited ventilation. We performed an evaluation of cold rooms at an airline catering facility because of concerns with exposure to cold temperatures. We spoke with and observed employees in two cold rooms, reviewed daily temperature logs, evaluated employee’s physical activity, work/rest schedule, and protective clothing. We measured temperature, percent relative humidity, and air velocities at different work stations inside the cold rooms. We concluded that thermal comfort concerns perceived by cold room employees may have been the result of air drafts at their workstations, insufficient use of personal protective equipment due to dexterity concerns, work practices, and lack of knowledge about good health and safety practices in cold rooms. These moderately cold work conditions with low air velocities are not well covered in current occupational health and safety guidelines, and wind chill calculations do not apply. We provide practical recommendations to improve thermal comfort of cold room employees. Engineering control recommendations include the redesigning of air deflectors and installing of suspended baffles. Administrative controls include the changing out of wet clothing, providing hand warmers outside of cold rooms, and educating employees on cold stress. We also recommended providing more options on personal protective equipment. However, there is a need for guidelines and educational materials tailored to employees in moderately cold environments to improve thermal comfort and minimize health and safety problems. PMID:25961447

  9. Conceptual designs and cost estimates of mechanical draft wet/dry and natural draft dry cooling systems using Curtiss-Wright integral fin-tube heat exchangers

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Haberski, R.J.; Bentz, J.C.

    1979-04-01

    This study was performed to establish a conceptual design and cost evaluation of an advanced technology mechanical draft wet/dry and natural draft dry cooling systems for large electric power plants using a high performance integral fin-tube heat transfer surface. This study was part of an overall DOE program to develop and demonstrate advanced concept cooling systems for large electric power plants. The results obtained show significant economic advantages compared to results previously published for conventional cooling systems. These advantages are due to the higher heat transfer and lower pressure loss which occur with the use of the selected multi-port integralmore » fin-tubes.« less

  10. 10 CFR Appendix N to Part 52 - Standardization of Nuclear Power Plant Designs: Combined Licenses To Construct and Operate...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... structures, systems, and components important to radiological health and safety and the common defense and... report on the environmental impacts of the common design. 5. Upon a determination that each application.... 6. The NRC staff shall prepare draft and final environmental impact statements for each of the...

  11. 75 FR 57103 - The Future of Aviation Advisory Committee (FAAC) Aviation Safety Subcommittee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

    ... evolving transportation needs, challenges, and opportunities of the global economy. The subcommittee will... develop a work plan for future meetings. DATES: The meeting will be held on September 28, 2010, from 2 to.... Review the status of issue items. 2. Discuss the drafting of recommendations and report. 3. Develop a...

  12. 78 FR 20312 - Downeast LNG, Inc., Downeast Pipeline, LLC.; Notice of Availability of the Supplemental Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... authorization to construct and operate a new liquefied natural gas (LNG) import terminal, natural gas pipeline... 500 million cubic feet per day of imported natural gas to the New England region. The Commission... Natural Gas Safety Research Report to Congress'' detailing the results of research conducted by Sandia...

  13. 77 FR 35395 - Draft Five-Year Plan (2013-2017) for the National Toxicology Program Interagency Center for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... innovations are driving transformative changes in toxicology and how safety testing is performed. The field of toxicology is evolving from a system based largely on animal testing toward one based on the integration of... methods that protect human and animal health and the environment while reducing, refining (enhancing...

  14. Scientific Opinion on Risk Assessment of Synthetic Biology.

    PubMed

    Epstein, Michelle M; Vermeire, Theo

    2016-08-01

    In 2013, three Scientific Committees of the European Commission (EC) drafted Scientific Opinions on synthetic biology that provide an operational definition and address risk assessment methodology, safety aspects, environmental risks, knowledge gaps, and research priorities. These Opinions contribute to the international discussions on the risk governance for synthetic biology developments. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. 75 FR 10307 - Notice of Availability of a Draft Environmental Impact Statement for Cape Hatteras National Seashore

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ... for the Cape Hatteras National Seashore (Seashore) Off-Road Vehicle Management Plan (Plan/EIS). The... off-road vehicle (ORV) use/access in the Seashore to protect and preserve natural and cultural... among various users, and to promote the safety of all visitors. Executive Order 11644 of 1972, amended...

  16. 78 FR 3824 - Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... available electronically at http://www.regulations.gov and at http://www.fda.gov/Food/ScienceResearch.... Available at: http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default...) Conducted in a Facility Co-Located on a Farm,'' 2012. Available at: http://www.fda.gov/ScienceResearch...

  17. Integrated Science Assessment (ISA) for Sulfur Oxides – Health Criteria (Second External Review Draft, Dec 2016)

    EPA Science Inventory

    This draft document provides EPA’s evaluation and synthesis of the most policy-relevant science related to the health effects of sulfur oxides. When final, it will provide a critical part of the scientific foundation for EPA’s decision regarding the adequacy of the current primar...

  18. 76 FR 79708 - Draft Environmental Impact Statement/General Management Plan, Golden Gate National Recreation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ...). The Plan/DEIS evaluates four alternatives for updating the current approach to management in Golden.... In recognition of the complexity of the proposed plan alternatives, and with deference to interest... DEPARTMENT OF THE INTERIOR National Park Service [NPS-PWR-PWRO-1108-8862; 2031-A038-409] Draft...

  19. Integrated Science Assessment (ISA) for Oxides of Nitrogen – Health Criteria (Second External Review Draft, 2015)

    EPA Science Inventory

    This draft document provides EPA’s evaluation and synthesis of the most policy-relevant science related to the health effects of oxides of nitrogen. When final, it will provide a critical part of the scientific foundation for EPA’s decision regarding the adequacy of the current ...

  20. 77 FR 12853 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver... the review of 351(k) applications and general scientific principles in conducting comparative analyses... specific, on the scientific considerations, Q&A, and quality considerations draft guidances. For example...

  1. Draft Genome Sequence of Xylella fastidiosa subsp. fastidiosa Strain Stag's Leap.

    PubMed

    Chen, J; Wu, F; Zheng, Z; Deng, X; Burbank, L P; Stenger, D C

    2016-04-21

    ITALIC! Xylella fastidiosasubsp. ITALIC! fastidiosacauses Pierce's disease of grapevine. Presented here is the draft genome sequence of the Stag's Leap strain, previously used in pathogenicity/virulence assays to evaluate grapevine germplasm bearing Pierce's disease resistance and a phenotypic assessment of knockout mutants to determine gene function. Copyright © 2016 Chen et al.

  2. 75 FR 68333 - Notice of Availability of a Draft Programmatic Environmental Impact Statement (PEIS) for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... YTC as well as significant but mitigable impacts to water resources at YTC. At PCMS, cumulative... assets to promote more effective training and force management. The Draft PEIS evaluates the... support integrated training with ground units. Land acquisition is not being considered as part of this...

  3. 75 FR 42085 - Workshop To Review Initial Health Effects Draft Materials for the Ozone (O3

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... Materials for the Ozone (O 3 ) Integrated Science Assessment (ISA) AGENCY: Environmental Protection Agency... evaluate initial draft materials for the health effects sections of the O 3 Integrated Science Assessment... of Research and Development (ORD). The workshop will be held on August 6, 2010, in Research Triangle...

  4. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7520 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

  5. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

  6. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...

  7. Drug interactions evaluation: An integrated part of risk assessment of therapeutics

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping

    2010-03-01

    Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industrymore » and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.« less

  8. The National Football League (NFL) combine: does normalized data better predict performance in the NFL draft?

    PubMed

    Robbins, Daniel W

    2010-11-01

    The objective of this study was to investigate the predictive ability of National Football League (NFL) combine physical test data to predict draft order over the years 2005-2009. The NFL combine provides a setting in which NFL personnel can evaluate top draft prospects. The predictive ability of combine data in its raw form and when normalized in both a ratio and allometric manner was examined for 17 positions. Data from 8 combine physical performance tests were correlated with draft order to determine the direction and strength of relationship between the various combine measures and draft order. Players invited to the combine and subsequently drafted in the same year (n = 1,155) were included in the study. The primary finding was that performance in the combine physical test battery, whether normalized or not, has little association with draft success. In terms of predicting draft order from outcomes of the 8 tests making up the combine battery, normalized data provided no advantage over raw data. Of the 8 performance measures investigated, straight sprint time and jumping ability seem to hold the most weight with NFL personnel responsible for draft decisions. The NFL should consider revising the combine test battery to reflect the physical characteristics it deems important. It may be that NFL teams are more interested in attributes other than the purely physical traits reflected in the combine test battery. Players with aspirations of entering the NFL may be well advised to develop mental and technical skills in addition to developing the physical characteristics necessary to optimize performance.

  9. Clinical Practice Guideline: Safe Medication Use in the ICU.

    PubMed

    Kane-Gill, Sandra L; Dasta, Joseph F; Buckley, Mitchell S; Devabhakthuni, Sandeep; Liu, Michael; Cohen, Henry; George, Elisabeth L; Pohlman, Anne S; Agarwal, Swati; Henneman, Elizabeth A; Bejian, Sharon M; Berenholtz, Sean M; Pepin, Jodie L; Scanlon, Mathew C; Smith, Brian S

    2017-09-01

    To provide ICU clinicians with evidence-based guidance on safe medication use practices for the critically ill. PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, and ISI Web of Science for relevant material to December 2015. Based on three key components: 1) environment and patients, 2) the medication use process, and 3) the patient safety surveillance system. The committee collectively developed Population, Intervention, Comparator, Outcome questions and quality of evidence statements pertaining to medication errors and adverse drug events addressing the key components. A total of 34 Population, Intervention, Comparator, Outcome questions, five quality of evidence statements, and one commentary on disclosure was developed. Subcommittee members were assigned selected Population, Intervention, Comparator, Outcome questions or quality of evidence statements. Subcommittee members completed their Grading of Recommendations Assessment, Development, and Evaluation of the question with his/her quality of evidence assessment and proposed strength of recommendation, then the draft was reviewed by the relevant subcommittee. The subcommittee collectively reviewed the evidence profiles for each question they developed. After the draft was discussed and approved by the entire committee, then the document was circulated among all members for voting on the quality of evidence and strength of recommendation. The committee followed the principles of the Grading of Recommendations Assessment, Development, and Evaluation system to determine quality of evidence and strength of recommendations. This guideline evaluates the ICU environment as a risk for medication-related events and the environmental changes that are possible to improve safe medication use. Prevention strategies for medication-related events are reviewed by medication use process node (prescribing, distribution, administration, monitoring). Detailed considerations to an active surveillance system that includes reporting, identification, and evaluation are discussed. Also, highlighted is the need for future research for safe medication practices that is specific to critically ill patients.

  10. High-Resolution 3-T Magnetic Resonance Imaging of the Shoulder in Nonsymptomatic Professional Baseball Pitcher Draft Picks.

    PubMed

    Del Grande, Filippo; Aro, Michael; Jalali Farahani, Sahar; Cosgarea, Andrew; Wilckens, John; Carrino, John A

    2016-01-01

    To retrospectively assess the qualitative and quantitative high-resolution 3-T magnetic resonance imaging (MRI) findings in nonsymptomatic baseball pitcher draft picks. Institutional review board-approved and HIPAA compliant study. Three-Tesla MRI of the dominant shoulder of 19 asymptomatic baseball pitcher draft picks and detailed clinical examination was performed before contract signing. Two radiologists performed independently qualitative and quantitative evaluation of shoulder structures. Descriptive statistics were performed. Sixty-eight percent (13/19), 32% (6/19), and 21% (4/19) of the baseball pitcher draft picks showed tendinopathy, partial thickness tendon tear of the supraspinatus, and acromioclavicular joint osteoarthritis, respectively. Glenohumeral subluxation, glenoid remodeling, and Bennett lesion were present in 53% (10/19), 79% (15/19), and 21% (4/19) of the subjects, respectively. Interclass coefficient was 0.633 to 0.863 and κ was 0.27 to 1. In asymptomatic baseball pitcher draft picks, 3-T MRI frequently shows abnormalities involving rotator cuff tendons, the coracohumeral, inferior glenohumeral, labrum, and osseous structures.

  11. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide ...

    EPA Pesticide Factsheets

    On September 22, 2006, the draft Evaluation of the Carinogenicity of Ethylene Oxide (EPA/635/R-06/003) and the draft charge to external peer reviewers were released for external peer review and public comment. This draft was reviewed by EPA’s Science Advisory Board (SAB) and the expert panel’s final report was made available December 21, 2007. Since that time the Agency implemented the May 2009 IRIS assessment development process in which other federal agencies and the Executive Offices of the President are provided two opportunities to comment on IRIS human health assessments; Interagency Science Consultation (Step 3) prior to public comment/peer review and Interagency Science Discussion (Step 6b) following peer review. In July, 2011, the draft assessment incorporating the SAB recommendations (December 2007) was sent to other federal agencies and Executive Offices of the President as part of Step 6 of the IRIS process. Following the May 2009 process, all written comments submitted by other agencies will be made publicly available. Accordingly, the interagency comments for ethylene oxide and the interagency science discussion materials provided to the other agencies are posted on this site. Note: After further consideration EPA has decided to undertake an additional peer review of the revised draft assessment on how the Agency responded to the SAB panel recommendations (December 2007), the exposure-response modeling of epidemiologic data, including n

  12. Methods and strategies for future reactor safety goals

    NASA Astrophysics Data System (ADS)

    Arndt, Steven Andrew

    There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk-informed analyses and discussions. This dissertation examines potential approaches to updating the safety goals that include the establishment of new quantitative safety goal associated with the comparative risk of generating electricity by viable competing technologies and modifications of the goals to account for multi-plant reactor sites, and issues associated with the use of safety goals in both initial licensing and operational decision making. This research develops a new quantitative health objective that uses a comparable benefit risk metric based on the life-cycle risk of the construction, operation and decommissioning of a comparable non-nuclear electric generation facility, as well as the risks associated with mining and transportation. This dissertation also evaluates the effects of using various methods for aggregating site risk as a safety metric, as opposed to using single plant safety goals. Additionally, a number of important assumptions inherent in the current safety goals, including the effect of other potential negative societal effects such as the generation of greenhouse gases (e.g., carbon dioxide) have on the risk of electric power production and their effects on the setting of safety goals, is explored. Finally, the role risk perception should play in establishing safety goals has been explored. To complete this evaluation, a new method to analytically compare alternative technologies of generating electricity was developed, including development of a new way to evaluate risk perception, and a new method was developed for evaluating the risk at multiple units on a single site. To test these modifications to the safety goals a number of possible reactor designs and configurations were evaluated using these new proposed safety goals to determine the goals' usefulness and utility. The results of the analysis showed that the modifications provide measures that more closely evaluate the potential risk to the public from the operation of nuclear power plants than the current safety goals, while still providing a straight-forward process for assessment of reactor design and operation.

  13. Legal Background of Aviation Medicine in Europe and its future development

    PubMed Central

    Siedenburg, J

    2008-01-01

    European aviation is moving into an exciting phase now, the administrative structure is changing. Aviation rules and aviation medicine will get a new structure as well. The nature of air traffic required an international scope in rulemaking – especially in such a confined continent as Europe with 41 countries, about 380 Million inhabitants and 317 billion person kilometres flown each year. For economic reasons it became necessary to develop common standards for certification of aircraft in the beginning of the 1970ies, maintenance followed later on. The Cyprus arrangement of 01 July 1990 created the JAA (Joint Aviation Authorities). Joint Aviation Requirements were drafted to replace existing national provisions and have been implemented from the end of the 1990ies. The areas of air operations and pilot licensing have been covered as well. The latter comprises of aviation medicine as well. The implementation of JAR-FCL 3, which covers the medical requirements for pilots, started from 1999 on in the several JAA member states. A detailed overview about development and structure of JAA, tools for harmonisation, rulemaking and amendment of requirements, medical standards, review procedures for contentious or marginal cases is described. Shortcomings were the fact that implementation was left to the discretion of the member states and that JAA had no executive power. This resulted in differences in safety and the EU commission concluded that aviation safety had to be regulated by the EU commission. After adoption of EU regulation 1592/2002 in 2002 common and binding requirements were to be drafted and a European aviation agency to be founded. EASA (European Aviation Safety Agency) started its work in September 2003. Finally it will take over the role of JAA completely. Whereas Certification and Maintenance were in the focus first, Flight Operations and Licensing are going to be covered as well in the near future. Essential Requirements have been drafted, outlining – inter alia – the scope of Licensing and of aeromedical aspects. However, the legislative process will most probably last at least until the end of 2007. Implementing Rules - being based on existing JAR-FCLs will be drafted soon and are going to be implemented as soon as EASA is operative for Licensing. JAR-FCL 3 will be the basis for the Implementing Rules concerning aeromedical fitness. An overview about the structure of the Agency, rulemaking procedures, philosophy of medical provisions and the transition from JAA to EASA is described. PMID:19048095

  14. 76 FR 54533 - Pipeline Safety: Issuance of Draft Decision on GexCon US, Inc. Petition for Approval of Flame...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    ... inspection at Docket No. PHMSA-2011-0101 at http://www.regulations.gov . DATES: Submit comments by September... following ways: E-Gov Website: http://www.regulations.gov . This Web site allows the public to enter... comments received will be posted without change to http://www.regulations.gov , including any personal...

  15. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5... departments, and manufacturers of enteral feeding tubes regarding luer lock misconnections. FDA advised... for Enteral Applications,'' you may either send an email request to [email protected] to receive an...

  16. 76 FR 77234 - Availability of Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-12

    ... From the Island of Vieques, Puerto Rico AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR... Environmental, Biological, and Health Data from the Island of Vieques, Puerto Rico for review and comment. This... health and the residents of Vieques, Puerto Rico. The Draft Vieques Report is available in English and...

  17. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms September 10, 1947 to September 15, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from September 10, 1947 to September 15, 1947, are presented.

  18. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms August 13, 1947 to August 15, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from August 13, 1947 to August 15, 1947 are presented.

  19. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms August 16, 1947 to August 20, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from August 16, 1947 to August 20, 1947 are presented.

  20. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms September 4, 1947 to September 5, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from September 4, 1947 to September 5, 1947 are presented.

  1. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms June 11, 1947 to July 11, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from June 11, 1947 to July 11, 1947 are presented.

  2. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms June 2, 1947 to June 7, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from June 2, 1947 to June 7, 1947, are presented.

  3. Evaluation of Gust and Draft Velocities from Flights of F-61C Airplanes within Thunderstorms August 7, 1947 to August 13, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1948-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61C airplanes participating in thunderstorm flights at Clinton County Army Air FIeld, Ohio, from August 7, 1947 to August 13, 1947 are presented.

  4. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms July 12, 1947 to July 18, 1947 at Clinton County Army Air Field, Ohio

    NASA Technical Reports Server (NTRS)

    Funk, Jack

    1947-01-01

    The gust and draft velocities from records of NACA instruments installed in P-61c airplanes participating in thunderstorm flights at Clinton County Army Air Field, Ohio, from July 12, to July 18, 1947 are presented.

  5. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms September 11, 1946 to September 16, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1947-01-01

    The results obtained from measurements of gust velocities, draft velocities, and ambient-air temperature within thunderstorms for the period from September 11, 1946 to September 16, 1946 at Orlando, Florida are presented herein. These data are summarized in.and presented.

  6. Integrated Science Assessment (ISA) for Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter Ecological Criteria (Second External Review Draft)

    EPA Science Inventory

    This draft Integrated Science Assessment (ISA) represents a concise synthesis and evaluation of the most policy-relevant science and will ultimately provide the scientific bases for EPA’s decision on retaining or revising the current secondary standards for NO2, SO

  7. 78 FR 57624 - Availability of a Draft Integrated Feasibility Report (Feasibility Study/Environmental Impact...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... Restoration Study, Los Angeles County, CA, for review and comment. The study evaluates alternatives for the... physical processes such as a more natural hydrologic and hydraulic regime that reconnects the river to... on November 28, 2008 (73 FR 72455). DATES: The Draft IFR is available for a 45-day review period from...

  8. 78 FR 12764 - Draft Office of Health Assessment and Translation Approach for Systematic Review and Evidence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... Approach--February 2013 might be needed, OHAT plans to apply it to two case-study evaluations. One case... Availability: Draft OHAT Approach--February 2013 will be available by February 26, 2013, and case-study... framework, describe the contents in the case-study protocols, and respond to questions from the public on...

  9. An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate (Dbp) Case Study (External Review Draft)

    EPA Science Inventory

    This draft report is a description of an approach to evaluate genomic data for use in risk assessment and a case study to illustrate the approach. The dibutyl phthalate (DBP) case study example focuses on male reproductive developmental effects and the qualitative application of...

  10. 78 FR 52525 - Dichloromethane and N-Methylpyrrolidone TSCA Chemical Risk Assessment; Notice of Public Meetings...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... Dichloromethane and N-Methylpyrrolidone.'' Dichloromethane and N-Methylpyrrolidone (DCM and NMP) (CASRN 75-09-2... represent and should not be construed to represent any Agency determination or policy. The draft DCM and NMP..., to assemble a panel of experts to evaluate the draft DCM and NMP TSCA risk assessment report for...

  11. Workshop to Obtain Input on Draft Materials for the Integrated Science Assessment (ISA) for Sulfur Oxides (SOx): Health Criteria

    EPA Science Inventory

    As part of the review of the air quality criteria for sulfur oxides (SOX) and primary (health-based) National Ambient Air Quality Standards (NAAQS) for sulfur dioxide (SO2), EPA is announcing a teleconference workshop to evaluate preliminary draft materials ...

  12. 75 FR 5768 - Intent To Prepare a Draft Environmental Impact Statement To Evaluate Improvements to the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-04

    ... DEPARTMENT OF DEFENSE Department of the Army; Corps of Engineers Intent To Prepare a Draft... Feasibility Report investigated increased widths and depths in the Pascagoula and Bayou Casotte navigation... Gulf Entrance channel to 44 feet by 550 feet from the 44-foot depth contour in the Gulf of Mexico to...

  13. Guidelines for economic analysis of pharmaceutical products: a draft document for Ontario and Canada.

    PubMed

    Detsky, A S

    1993-05-01

    In Canada, provincial formulary review committees consider the effectiveness, safety, and cost of products when they derive advice for each Minister of Health. This article offers a draft set of guidelines for pharmaceutical manufacturers making submissions which include economic information, moving beyond a simple presentation of the unit price of the pharmaceutical product (e.g. price per day or course of therapy) and comparison to similar prices for alternative products. A full economic analysis compares all relevant costs and clinical outcomes of the new product with alternate therapeutic strategies for treating patients with a particular condition. The perspective of the decision maker must be clearly identified. The quality of the evidence supporting estimates of the variables incorporated in the analysis should be evaluated. Sensitivity analyses are used to assess the robustness of the qualitative conclusions. Reviewers will examine the answers to a set of 19 questions. Manufacturers can use these questions as a worksheet for preparation of an economic analysis to be incorporated in a submission. These guidelines are intended to be a starting point for further refinement, and discussion with health economists in industry and academia. Considerable flexibility will be used in reviewing documentation supporting economic analysis. Those preparing submissions should be encouraged to experiment with various approaches as part of the general development of this field and to engage provincial review committees in ongoing discussions.

  14. Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Vovk, I.F.; Seitz, R.R.

    1995-12-31

    The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safetymore » assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.« less

  15. Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Coleman, Justin Leigh; Kammerer, Annie M.; Whittaker, Andrew S.

    Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report thatmore » investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, “Seismic Analysis of Safety Related Nuclear Structures.” The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design approach in 10 CFR 52 and a detailed discussion of seismic probabilistic risk assessments for isolated facilities.« less

  16. Born at the Wrong Time: Selection Bias in the NHL Draft

    PubMed Central

    Deaner, Robert O.; Lowen, Aaron; Cobley, Stephen

    2013-01-01

    Relative age effects (RAEs) occur when those who are relatively older for their age group are more likely to succeed. RAEs occur reliably in some educational and athletic contexts, yet the causal mechanisms remain unclear. Here we provide the first direct test of one mechanism, selection bias, which can be defined as evaluators granting fewer opportunities to relatively younger individuals than is warranted by their latent ability. Because RAEs are well-established in hockey, we analyzed National Hockey League (NHL) drafts from 1980 to 2006. Compared to those born in the first quarter (i.e., January–March), those born in the third and fourth quarters were drafted more than 40 slots later than their productivity warranted, and they were roughly twice as likely to reach career benchmarks, such as 400 games played or 200 points scored. This selection bias in drafting did not decrease over time, apparently continues to occur, and reduces the playing opportunities of relatively younger players. This bias is remarkable because it is exhibited by professional decision makers evaluating adults in a context where RAEs have been widely publicized. Thus, selection bias based on relative age may be pervasive. PMID:23460902

  17. Improved motors for utility applications: Volume 6, Squirrel-cage rotor analysis: Final report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Griffith, J.W.; McCoy, R.M.

    1986-11-01

    An analysis of squirrel cage induction motor rotors was undertaken in response to an Industry Assessment Study finding 10% of motor failures to be rotor related. The analysis focuses on evaluating rotor design life. The evaluation combines state-of-the-art electromagnetic, thermal, and structural solution techniques into an integrated analysis and presents a simple summary. Finite element techniques are central tools in the analysis. The analysis is applied to a specific forced draft fan drive design. Fans as a category of application have a higher failure rate than other categories of power station auxiliary motor applications. Forced-draft fan drives are one ofmore » the major fan drives which accelerate a relatively high value of rotor load inertia. Various starting and operating conditions are studied for this forced-draft fan drive motor including a representative application duty cycle.« less

  18. 77 FR 277 - Sabine Pass Liquefaction, LLC and Sabine Pass LNG, L.P; Notice of Availability of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-04

    ... Web site ( www.ferc.gov ) using the eLibrary link. A limited number of copies of the EA are available..., or on the FERC Web site ( www.ferc.gov ) using the eLibrary link. Click on the eLibrary link, click... systems, induced draft air coolers, fire and gas detection and safety systems, control systems, and...

  19. Interpretation of aged sorption studies for pesticides and their use in European Union regulatory leaching assessments.

    PubMed

    Beulke, Sabine; van Beinum, Wendy; Suddaby, Laura

    2015-04-01

    First-tier regulatory exposure assessments for pesticides assume that pesticide sorption is instantaneous and fully reversible. In European Union (EU) regulatory guidance, an increase in sorption over time ("aged sorption") can be considered at the higher tier to refine predicted environmental concentrations in groundwater. Research commissioned by the UK Chemicals Regulation Directorate (CRD), funded by the Department for Environment Food & Rural Affairs (Defra), formed the basis of a draft regulatory guidance document proposing 1) a protocol on how to measure aged sorption of parent compounds in laboratory studies, 2) procedures to fit kinetic models to the experimental data, 3) criteria to test the reliability of the parameters, and 4) procedures for use of the parameters in the groundwater exposure assessment. The draft guidance was revised after feedback from stakeholders and testing of the guidance was performed against real data sets by an independent consultancy. The Chemicals Regulation Directorate submitted the revised document to the European Food Safety Authority (EFSA) for scrutiny. This article gives an overview of the draft guidance and explains the reasoning behind the recommendations made. 2015 Crown Copyright; Published 2015 SETAC.

  20. Fuel Cell Transit Bus Coordination and Evaluation Plan California Fuel Cell Transit Evaluation Team, DRAFT

    DOT National Transportation Integrated Search

    2003-10-29

    The objective of the DOE/NREL evaluation program is to provide comprehensive, unbiased evaluation results of advanced technology vehicle development and operations, evaluation of hydrogen infrastructure development and operation, and descriptions of ...

  1. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide ...

    EPA Pesticide Factsheets

    In December 2016, EPA finalized its Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide. EPA’s evaluation was reviewed internally by EPA and by other federal agencies and White House Offices in October 2016, before public release. Consistent with the May 2009 IRIS assessment development process, all written comments on IRIS assessments submitted by other federal agencies and White House Offices are made publicly available. Accordingly, interagency comments and the interagency science discussion materials provided to other agencies, including interagency review drafts of the EPA’s Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide, are posted on this site. Note: No major science comments were received on the Interagency Science Discussion Draft. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White House Offices before public release. Consistent with the May 2009 IRIS assessment development process, all written comments on IRIS assessments submitted by other federal agencies and White House Offices are made publicly available. Accordingly, interagency comments and the interagency science consultation materials provided to other agencies, including interagency review drafts of the IRIS Toxicological Review of Ammonia and the charge to external peer reviewers, are posted on this site.

  2. Evaluation of Gust and Draft Velocities from Flights of P-61c Airplanes within Thunderstorms August 7, 1946 to August 13, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, Harold B.

    1946-01-01

    This report presents the results obtained from gust and draft velocity measurements within thunderstorms for the period August 7, 1946 to August, 13, 1946 at Orlando Florida. In several of the surveys, indications of ambient air temperature were obtained from photo-observer records. These data are summarized in the report.

  3. 78 FR 79706 - Office of the Assistant Secretary-Water and Science; Draft Environmental Assessment of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-31

    ...The Department of the Interior (Department), the Utah Reclamation Mitigation and Conservation Commission (Mitigation Commission), and the Central Utah Water Conservancy District (CUWCD), as joint leads, are evaluating the impacts of a proposed increase in operation, maintenance and replacement activities associated with the Wasatch County Water Efficiency Project (WCWEP) and have prepared a Draft Environmental Assessment.

  4. Integrated Science Assessment (ISA) for Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter - Ecological Criteria (First External Review Draft, Mar 2017)

    EPA Science Inventory

    This draft ISA document represents a concise synthesis and evaluation of the most policy-relevant science and will ultimately provide the scientific bases for EPA’s decision on retaining or revising the current secondary standards for NO2, SO2, PM 2.5 and PM 10 since the prior re...

  5. Fiscal year 1981 US corn and soybeans pilot preliminary experiment plan, phase 1

    NASA Technical Reports Server (NTRS)

    Livingston, G. P.; Nedelman, K. S.; Norwood, D. F.; Smith, J. H. (Principal Investigator)

    1981-01-01

    A draft of the preliminary experiment plan for the foreign commodity production forecasting project fiscal year 1981 is presented. This draft plan includes: definition of the phase 1 and 2 U.S. pilot objectives; the proposed experiment design to evaluate crop calendar, area estimation, and area aggregation components for corn and soybean technologies using 1978/1979 crop-year data; a description of individual sensitivity evaluations of the baseline corn and soybean segment classification procedure; and technology and data assessment in support of the corn and soybean estimation technology for use in the U.S. central corn belt.

  6. The Brief Pain Inventory and its "pain at its worst in the last 24 hours" item: clinical trial endpoint considerations.

    PubMed

    Atkinson, Thomas M; Mendoza, Tito R; Sit, Laura; Passik, Steven; Scher, Howard I; Cleeland, Charles; Basch, Ethan

    2010-03-01

    In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.

  7. Outstanding Questions In First Amendment Law Related To Food Labeling Disclosure Requirements For Health.

    PubMed

    Pomeranz, Jennifer L

    2015-11-01

    The federal and state governments are increasingly focusing on food labeling as a method to support good health. Many such laws are opposed by the food industry and may be challenged in court, raising the question of what is legally feasible. This article analyzes outstanding questions in First Amendment law related to commercial disclosure requirements and conducts legal analysis and policy evaluation for three current policies. These include the Food and Drug Administration's draft regulation requiring an added sugar disclosure on the Nutrition Facts panel, California's proposed sugar-sweetened beverage safety warning label bill, and Vermont's law requiring labels of genetically engineered food to disclose this information. I recommend several methods for policy makers to enact food labeling laws within First Amendment parameters, including imposing factual commercial disclosure requirements, disclosing the government entity issuing a warning, collecting evidence, and identifying legitimate governmental interests. Project HOPE—The People-to-People Health Foundation, Inc.

  8. The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Posas, Paula J., E-mail: pjposas@gmail.co

    2011-04-15

    The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment,more » and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.« less

  9. Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

    PubMed

    Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

    2008-07-01

    The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

  10. [Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations].

    PubMed

    Ubago Pérez, Ruth; Castillo Muñoz, María Auxiliadora; Banqueri, Mercedes Galván; García Estepa, Raúl; Alfaro Lara, Eva Rocío; Vega Coca, María Dolores; Beltrán Calvo, Carmen; Molina López, Teresa

    The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model ® , has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting "Evidence synthesis reports: pharmaceuticals" in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model ® . In this paper, the methodology that AETSA has developed to create the guideline for "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Statistical properties of a cloud ensemble - A numerical study

    NASA Technical Reports Server (NTRS)

    Tao, Wei-Kuo; Simpson, Joanne; Soong, Su-Tzai

    1987-01-01

    The statistical properties of cloud ensembles under a specified large-scale environment, such as mass flux by cloud drafts and vertical velocity as well as the condensation and evaporation associated with these cloud drafts, are examined using a three-dimensional numerical cloud ensemble model described by Soong and Ogura (1980) and Tao and Soong (1986). The cloud drafts are classified as active and inactive, and separate contributions to cloud statistics in areas of different cloud activity are then evaluated. The model results compare well with results obtained from aircraft measurements of a well-organized ITCZ rainband that occurred on August 12, 1974, during the Global Atmospheric Research Program's Atlantic Tropical Experiment.

  12. [Topical issues of biological safety under current conditions. Part 3. Scientific provision for the national regulation of the biological safety framework in its broad interpretation].

    PubMed

    Onishchenko, G G; Smolensky, V Yu; Ezhlova, E B; Demina, Yu V; Toporkov, V P; Toporkov, A V; Lyapin, M N; Kutyrev, V V

    2014-01-01

    Consequent of investigation concerned with biological safety (BS) framework development in its broad interpretation, reflected in the Russian Federation State Acts, identified have been conceptual entity parameters of the up-to-date broad interpretation of BS, which have formed a part of the developed by the authors system for surveillance (prophylaxis, localization, indication, identification, and diagnostics) and control (prophylaxis, localization, and response/elimination) over the emergency situations of biological (sanitary-epidemiological) character. The System functionality is activated through supplying the content with information data which are concerned with monitoring and control of specific internal and external threats in the sphere of BS provision fixed in the Supplement 2 of the International Health Regulations (IHR, 2005), and with the previously characterized nomenclature of hazardous biological factors. The system is designed as a network-based research-and-practice tool for evaluation of the situation in the sphere of BS provision, as well as assessment of efficacy of management decision making as regards BS control and proper State policy implementation. Most of the system elements either directly or indirectly relate to the scope of activities conducted by Federal Service for Surveillance in the Sphere of Consumers Rights Protection and Human Welfare, being substantial argument for allocating coordination functions in the sphere of BS provision to this government agency and consistent with its function as the State Coordinator on IHR (2005). The data collected serve as materials to Draft Federal Law "Concerning biological safety provision of the population".

  13. An attempt to implement tools to support examination of community-based activities for disaster mitigation: A case study in Toyokawa city, Japan

    NASA Astrophysics Data System (ADS)

    Karashima, Kazuki; Ohgai, Akira

    2017-10-01

    Japan is a country with a high risk for earthquake disasters. The measures used to promote structures' seismic safety, such as reconstruction, widening narrow roads, and the response capacities to deal with huge earthquakes are important. Techniques to support the examination of countermeasures to huge earthquakes are required. To improve this capability, the authors developed tools to: (1) evaluate fire-spread risk, (2) evaluate the difficulty of emergency response and evacuation, and (3) evaluate capacities of neighborhood communities for disaster mitigation. The usefulness of the tools was clarified by the demonstration experiments of previous studies. The next step was implementation of the tools in community-based activities for disaster mitigation. This study aimed to clarify the usability and problems of implementing the tools in community-based activities. The tools were used at several workshops in actual community-based activities for disaster mitigation for one year. After the last workshop, interviews and a questionnaire were conducted on municipal staff and consultant staff. The results found that the tools visually showed the fire-spread risk, the difficulty of evacuation under current conditions and after improvements, and the effects of each disaster mitigation activity. The users could easily explore the draft plans to promote seismic safety of urban structures and response capabilities. The tools were positively incorporated into some community-based activities for disaster mitigation. Thus, the tools have the possibility of successful use at continuing community-based activities and the possibility of implementing the tools will be promoted.

  14. ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

    PubMed

    Cavero, Icilio; Crumb, William

    2005-05-01

    The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a draft form since 2001. The S7A guideline deals with general principles and recommendations on safety pharmacology studies designed to protect healthy volunteers and patients from potential drug-induced adverse reactions. The S7B recommends a general non-clinical testing strategy for determining the propensity of non-cardiovascular pharmaceuticals to delay ventricular repolarisation, an effect that at times progresses into life-threatening ventricular arrhythmia. In the most recent version of this document (June 2004), the strategy proposes experimental assays and a critical examination of other pertinent information for applying an 'evidence of risk' label to a compound. Regrettably, the guideline fails to deal satisfactorily with a number of crucial issues such as scoring the evidence of risk and the clinical consequences of such scoring. However, in the latter case, the S7B relies on the new ICH guideline E14 which is currently in preparation. E14 is the clinical counterpart of the S7B guideline which states that non-clinical data are a poor predictor of drug-induced repolarisation delay in humans. The present contribution summarises and assesses salient aspects of the S7A guideline as its founding principles are also applicable to the S7B guideline. The differences in strategies proposed by the various existing drafts of the latter document are critically examined together with some unresolved, crucial problems. The need for extending the objective of the S7B document to characterise the full electrophysiological profile of new pharmaceuticals is argued as this approach would more extensively assess the non-clinical cardiac safety of a drug. Finally, in order to overcome present difficulties in arriving at the definitive version of the S7B guideline, the Expert Working Group could reflect on the introduction of the S7B guideline recommendations in the S7A document, as originally intended, or on postponing the adoption of an harmonized text until the availability of novel scientific data allows solving presently contentious aspects of this and the E14 guidelines.

  15. TU-FG-209-04: Testing of Digital Image Receptors Using AAPM TG-150’s Draft Recommendations - Investigating the Impact of Different Processing Parameters

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Finley, C; Dave, J

    Purpose: To evaluate implementation of AAPM TG-150’s draft recommendations via a parameter study for testing the performance of digital image receptors. Methods: Flat field images were acquired from 9 calibrated digital image receptors associated with 9 new portable digital radiography systems (Carestream Health, Inc.) based on the draft recommendations and manufacturer-specified calibration conditions (set of 4 images at input detector air kerma ranging from 1 to 25 µGy). Effects of exposure response function (linearized and logarithmic), ‘Presentation Intent Type’ (‘For Processing’ and ‘For Presentation’), detector orientation with respect to the anode-cathode axis (4 orientations; 900 rotations per iteration), different ROImore » sizes (5×5–40×40 mm{sup 2}) and elimination of varying dimensions of image border (0 mm i.e., without boundary elimination to 150 mm) on signal, noise, signal-to-noise ratio (SNR) and the associated nonuniformities were evaluated. Images were analyzed in Matlab and quantities were compared using ANOVA. Results: Signal, noise and SNR values averaged over 9 systems with default parameter values in draft recommendations were 4837.2±139.4, 19.7±0.9 and 246.4±10.1 (mean ± standard deviation), respectively (at input detector air kerma: 12.5 µGy). Signal, noise and SNR showed characteristic dependency on exposure response function and on ‘Presentation Intent Type’. These values were not affected by ROI size and detector orientation, but analysis showed that eliminating the edge pixels along the boundary was required for the noise parameter (coefficient of variation range for noise: 72%–106% and 3%–4% without and with boundary elimination; respectively). Local and global nonuniformities showed a similar dependence on the need for boundary elimination. Interestingly, computed non-uniformities showed agreement with manufacturer-reported values except for noise non-uniformities in two units; artifacts were seen in images from these two units highlighting the importance of independent evaluations. Conclusion: The effect of different parameters on performance characterization of digital image receptors was evaluated based on TG-150’s draft recommendations.« less

  16. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised Publication Guidelines from a Detailed Consensus Process

    PubMed Central

    Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

    2015-01-01

    Since the publication of Standards for Quality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015, using 1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group; 2) two face-to-face consensus meetings to develop interim drafts; and 3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). PMID:26517437

  17. Representation of occupational information across resources and validation of the occupational data for health model.

    PubMed

    Rajamani, Sripriya; Chen, Elizabeth S; Lindemann, Elizabeth; Aldekhyyel, Ranyah; Wang, Yan; Melton, Genevieve B

    2018-02-01

    Reports by the National Academy of Medicine and leading public health organizations advocate including occupational information as part of an individual's social context. Given recent National Academy of Medicine recommendations on occupation-related data in the electronic health record, there is a critical need for improved representation. The National Institute for Occupational Safety and Health has developed an Occupational Data for Health (ODH) model, currently in draft format. This study aimed to validate the ODH model by mapping occupation-related elements from resources representing recommendations, standards, public health reports and surveys, and research measures, along with preliminary evaluation of associated value sets. All 247 occupation-related items across 20 resources mapped to the ODH model. Recommended value sets had high variability across the evaluated resources. This study demonstrates the ODH model's value, the multifaceted nature of occupation information, and the critical need for occupation value sets to support clinical care, population health, and research. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  18. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process.

    PubMed

    Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

    2015-01-01

    In the past several years, the science of health care improvement has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes 3 key components of systematic efforts to improve the quality, value, and safety of health care: formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). © The Author(s) 2015.

  19. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised Publication Guidelines from a Detailed Consensus Process.

    PubMed

    Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

    2015-01-01

    Since the publication of Standards for Quality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015, using 1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group; 2) two face-to-face consensus meetings to develop interim drafts; and 3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org).

  20. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes Within Thunderstorms September 17, 1946 to September 18, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1947-01-01

    The results obtained from measurements of gust velocities, draft velocities, and ambient-air temperature within thunderstorms for the period September 17, 1946 to September 18, 1946 at Orlando, Fla. are presented herein. These data are summarized in tables I, II, and III, respectively, and are of the type presented in reference 1 for previous flights.

  1. Draft Genome Sequences of Two Novel Salmonella enterica subsp. enterica Strains Isolated from Low-Moisture Foods with Applications in Food Safety Research.

    PubMed

    Radford, Devon R; Leon-Velarde, Carlos G; Chen, Shu; Hamidi Oskouei, Amir M; Balamurugan, Sampathkumar

    2018-03-29

    The genomes of two strains of Salmonella enterica subsp. enterica serovar Cubana and serovar Muenchen, isolated from dry hazelnuts and chia seeds, respectively, were sequenced using the Illumina MiSeq platform, assembled de novo using the overlap-layout-consensus method, and aligned to their respective most identical sequence genome scaffolds using MUMMER and BLAST searches. Copyright © 2018 Radford et al.

  2. Environmental Assessment for the California Space Center at Vandenberg Air Force Base, California

    DTIC Science & Technology

    2010-04-08

    Occupational Safety and Health Administration P2 Pollution prevention Pb Lead PFC Perfluorocarbon PG& E Pacific Gas & Electric PM2.5 Particulate matter 2.5...services center, a commissary and staff lounge , a warehouse, Chapter 2. Description of the Proposed Action and Alternatives Final Draft...including tenants. Ultimately, the CSC would obtain service from Pacific Gas & Electric (PG& E ) for the entire Center, once a planned line is completed by

  3. Developmental contexts and sporting success: birth date and birthplace effects in national hockey league draftees 2000-2005.

    PubMed

    Baker, Joseph; Logan, A Jane

    2007-08-01

    To examine relative age and birth place effects in hockey players drafted to play in the National Hockey League (NHL) between 2000 and 2005 and determine whether these factors influenced when players were chosen in the draft. 1013 North American draftees were evaluated from the official NHL website, which provided birthplace, date of birth and selection order in the draft. Population size was collected from Canadian and American census information. Athletes were divided into four quartiles on the basis of selection date to define age cohorts in hockey. Data between the Canadian and American players were also compared to see if the optimal city sizes differed between the two nations. Relative age and birthplace effects were found, although the optimal city size found was dissimilar to that found in previous studies. Further, there were inconsistencies between the Canadian and American data. Contextual factors such as relative age and size of birthplace have a significant effect on likelihood of being selected in the NHL draft.

  4. The impact of peer review on paediatric forensic reports.

    PubMed

    Kariyawasam, Uditha

    2016-10-01

    To retrospectively evaluate the common grammar and spelling errors of the medico-legal reports written by the doctors at the Victorian Forensic Paediatric Medical Service (VFPMS) in both Royal Children's Hospital (RCH) and Monash Medical Centre. The reports were evaluated at two points in time; before and after peer review. The aim of the study was to ascertain whether peer review improved the grammar and spelling in VFPMS medico-legal reports. Draft VFPMS reports are sent to the VFPMS medical director for peer review. The current study sampled 50 reports that were sent consecutively to Dr. Anne Smith from 1st of May 2015. The 50 corresponding final reports were then retrieved from the VFPMS database. The 50 pairs of draft and final reports were scored using a 50-point scoring system. The scores of the draft reports were compared to the scores of the final report to assess if there was a change in quality as measured using an explicit criteria audit of report structure, simple grammar, jargon use and spelling. The audit did not include evaluation of the validity of forensic opinions. The overall scores were statistically analysed using descriptive statistics and a paired T-test. The scores of the reports improved by 2.24% when the final reports were compared to the draft reports (p < 0.001). The peer-review process resulted in a significantly higher quality of medico-legal reports. The report writing and peer-review process could be assisted by an abbreviated version of the checklist used for the audit. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

  5. 78 FR 7786 - International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and...

  6. Development and evaluation of a web-based software for crash data collection, processing and analysis.

    PubMed

    Montella, Alfonso; Chiaradonna, Salvatore; Criscuolo, Giorgio; De Martino, Salvatore

    2017-02-05

    First step of the development of an effective safety management system is to create reliable crash databases since the quality of decision making in road safety depends on the quality of the data on which decisions are based. Improving crash data is a worldwide priority, as highlighted in the Global Plan for the Decade of Action for Road Safety adopted by the United Nations, which recognizes that the overall goal of the plan will be attained improving the quality of data collection at the national, regional and global levels. Crash databases provide the basic information for effective highway safety efforts at any level of government, but lack of uniformity among countries and among the different jurisdictions in the same country is observed. Several existing databases show significant drawbacks which hinder their effective use for safety analysis and improvement. Furthermore, modern technologies offer great potential for significant improvements of existing methods and procedures for crash data collection, processing and analysis. To address these issues, in this paper we present the development and evaluation of a web-based platform-independent software for crash data collection, processing and analysis. The software is designed for mobile and desktop electronic devices and enables a guided and automated drafting of the crash report, assisting police officers both on-site and in the office. The software development was based both on the detailed critical review of existing Australasian, EU, and U.S. crash databases and software as well as on the continuous consultation with the stakeholders. The evaluation was carried out comparing the completeness, timeliness, and accuracy of crash data before and after the use of the software in the city of Vico Equense, in south of Italy showing significant advantages. The amount of collected information increased from 82 variables to 268 variables, i.e., a 227% increase. The time saving was more than one hour per crash, i.e., a 36% reduction. The on-site data collection did not produce time saving, however this is a temporary weakness that will be annihilated very soon in the future after officers are more acquainted with the software. The phase of evaluation, processing and analysis carried out in the office was dramatically shortened, i.e., a 69% reduction. Another benefit was the standardization which allowed fast and consistent data analysis and evaluation. Even if all these benefits are remarkable, the most valuable benefit of the new procedure was the reduction of the police officers mistakes during the manual operations of survey and data evaluation. Because of these benefits, the satisfaction questionnaires administrated to the police officers after the testing phase showed very good acceptance of the procedure. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. A simple tool for preliminary hazard identification and quick assessment in craftwork and small/medium enterprises (SME).

    PubMed

    Colombini, Daniela; Occhipinti, E; Di Leone, G

    2012-01-01

    During the last Congress of the International Ergonomics Association (IEA), Beijing, August 2009, an international group was founded aimed at developing a "toolkit for MSD prevention" within IEA and in collaboration with World Health Organization (WHO). Possible users of toolkits are: members of health and safety committees, health and safety representatives, line supervisors; labor inspectors; health workers implementing basic occupational health services; occupational health and safety specialists.According to ISO standard 11228 series and the new Draft CD ISO 12259-2009: Application document guides for the potential user, a computer software ( in Excel®) was create dealing with hazard "mapping" in handicraft The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazard identification and risk estimation. Thus it makes possible to decide for which professional hazards a more exhaustive risk assessment will be necessary and which professional consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).

  8. NTP monograph on health effects of low-level lead.

    PubMed

    2012-06-01

    Although reductions in lead (Pb) exposure for the U.S. population have resulted in lower blood Pb levels over time, epidemiological studies continue to provide evidence of health effects at lower and lower blood Pb levels. Low-level Pb was selected for evaluation by the National Toxicology Program (NTP) because of (1) the availability of a large number of epidemiological studies of Pb, (2) a nomination by the National Institute for Occupational Safety and Health for an assessment of Pb at lower levels of exposure, and (3) public concern for effects of Pb in children and adults. This evaluation summarizes the evidence in humans and presents conclusions on health effects in children and adults associated with low-level Pb exposure as indicated by less than 10 micrograms of Pb per deciliter of blood (< 10 microg/dL). The assessment focuses on epidemiological evidence at blood Pb levels < 10 microg/dL and < 5 microg/dL because health effects at higher blood Pb levels are well established. The NTP evaluation was conducted through the Office of Health Assessment and Translation (OHAT, formerly the Center for the Evaluation of Risks to Human Reproduction) and completed in April of 2012. The results of this evaluation are published in the NTP Monograph on Health Effects of Low-Level Lead. The document and appendices are available at http://ntp.niehs.nih.gov/go/evals. This document provides background on Pb exposure and includes a review of the primary epidemiological literature for evidence that low-level Pb is associated with neurological, immunological, cardiovascular, renal, and/or reproductive and developmental effects. The NTP Monograph presents specific conclusions for each health effect area. Overall, the NTP concludes that there is sufficient evidence that blood Pb levels < 10 microg/dL and < 5 microg/dL are associated with adverse health effects in children and adults. This conclusion was based on a review of the primary epidemiological literature, scientific input from technical advisors that reviewed pre-public release drafts of each chapter summarizing the evidence for specific health effects associated with low-level Pb, public comments received during the course of the evaluation, and comments from an expert panel of ad hoc reviewers during a public meeting to review the Draft NTP Monograph on November 17-18, 2011 (http://ntp.niehs.nih.gov/go/37090.

  9. Resequencing of the common marmoset genome improves genome assemblies and gene-coding sequence analysis.

    PubMed

    Sato, Kengo; Kuroki, Yoko; Kumita, Wakako; Fujiyama, Asao; Toyoda, Atsushi; Kawai, Jun; Iriki, Atsushi; Sasaki, Erika; Okano, Hideyuki; Sakakibara, Yasubumi

    2015-11-20

    The first draft of the common marmoset (Callithrix jacchus) genome was published by the Marmoset Genome Sequencing and Analysis Consortium. The draft was based on whole-genome shotgun sequencing, and the current assembly version is Callithrix_jacches-3.2.1, but there still exist 187,214 undetermined gap regions and supercontigs and relatively short contigs that are unmapped to chromosomes in the draft genome. We performed resequencing and assembly of the genome of common marmoset by deep sequencing with high-throughput sequencing technology. Several different sequence runs using Illumina sequencing platforms were executed, and 181 Gbp of high-quality bases including mate-pairs with long insert lengths of 3, 8, 20, and 40 Kbp were obtained, that is, approximately 60× coverage. The resequencing significantly improved the MGSAC draft genome sequence. The N50 of the contigs, which is a statistical measure used to evaluate assembly quality, doubled. As a result, 51% of the contigs (total length: 299 Mbp) that were unmapped to chromosomes in the MGSAC draft were merged with chromosomal contigs, and the improved genome sequence helped to detect 5,288 new genes that are homologous to human cDNAs and the gaps in 5,187 transcripts of the Ensembl gene annotations were completely filled.

  10. Evaluation Strategy. Paper Preservation Systems.

    ERIC Educational Resources Information Center

    FMC Corp., Gastonia, NC. Lithium Div.

    After a decade of slow but steady progress, the pace of development of technologies to deacidify and strengthen deteriorating books and documents has quickened significantly. These developments accentuate the need for the conservation community to scientifically evaluate the technical merits of potential processes. This draft evaluation strategy…

  11. 75 FR 8053 - A Framework for Categorizing the Relative Vulnerability of Threatened and Endangered Species to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... and Development. This draft document describes an evaluative framework that may be used to categorize... Climate Change'' describes an evaluative framework that may be used to categorize the relative...

  12. Silicon Valley Smart Corridor : draft evaluation strategy

    DOT National Transportation Integrated Search

    2000-06-05

    This document outlines the strategy for evaluating the integrated freeway, arterial, and incident management system known as the Silicon Valley Smart Corridor (SVSC). Centered in San Jose, California, the SVSC is one of approximately 65 deployments o...

  13. Evaluation in industry of a draft code of practice for manual handling.

    PubMed

    Ashby, Liz; Tappin, David; Bentley, Tim

    2004-05-01

    This paper reports findings from a study which evaluated the draft New Zealand Code of Practice for Manual Handling. The evaluation assessed the ease of use, applicability and validity of the Code and in particular the associated manual handling hazard assessment tools, within New Zealand industry. The Code was studied in a sample of eight companies from four sectors of industry. Subjective feedback and objective findings indicated that the Code was useful, applicable and informative. The manual handling hazard assessment tools incorporated in the Code could be adequately applied by most users, with risk assessment outcomes largely consistent with the findings of researchers using more specific ergonomics methodologies. However, some changes were recommended to the risk assessment tools to improve usability and validity. The evaluation concluded that both the Code and the tools within it would benefit from simplification, improved typography and layout, and industry-specific information on manual handling hazards.

  14. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms August 17, 1946 to August 19, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1947-01-01

    Results obtained from gust and draft velocity measurements within thunderstorms for the period August 17, 1946 to August 19, 1946 at Orlando, Florida are presented herein. These data are summarized in tables I and II and are of the type presented in reference 1 for previous flights. Inspection of photo-observer records taken on the present flights indicated that mo ambient-air temperature data were obtained.

  15. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms July 24, 1946 to August 6, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, Harold B.

    1947-01-01

    The results obtained from gust and draft velocity measurements within thunderstorms for the period July 24, 1946 to August 6, 1946 at Orlando, Florida are presented herein. These data are summarized in tables I and II and are of the type presented in reference 1 for previous flights. In two thunderstorm traverses, indications of ambient-air temperature were obtained from photo-observer records. These data are summarized in table III.

  16. Integrated Science Assessment (ISA) for Lead (Second ...

    EPA Pesticide Factsheets

    EPA has announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Lead (Pb) has been made available for independent peer review and public review. This draft ISA represents a concise synthesis and evaluation of the most policy-relevant science and will ultimately provide the scientific bases for EPA’s decision regarding whether the current standards for Pb sufficiently protect public health and the environment. Lead (Pb) is one of six principal (or criteria) pollutants for which EPA has established NAAQS

  17. Emergency Cooling of Nuclear Power Plant Reactors With Heat Removal By a Forced-Draft Cooling Tower

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Murav’ev, V. P., E-mail: murval1@mail.ru

    The feasibility of heat removal during emergency cooling of a reactor by a forced-draft cooling tower with accumulation of the peak heat release in a volume of precooled water is evaluated. The advantages of a cooling tower over a spray cooling pond are demonstrated: it requires less space, consumes less material, employs shorter lines in the heat removal system, and provides considerably better protection of the environment from wetting by entrained moisture.

  18. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ...The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.

  19. Organizational member involvement in physical activity coalitions across the United States: development and testing of a novel survey instrument for assessing coalition functioning.

    PubMed

    Bornstein, Daniel B; Pate, Russell R; Beets, Michael W; Saunders, Ruth P; Blair, Steven N

    2015-06-01

    Coalitions are often composed of member organizations. Member involvement is thought to be associated with coalition success. No instrument currently exists for evaluating organizational member involvement in physical activity coalitions. This study aimed to develop a survey instrument for evaluating organizational member involvement in physical activity coalitions. The study was carried out in three phases: (a) developing a draft survey, (b) assessing the content validity of the draft survey, and (c) assessing the underlying factor structure, reliability, and validity of the survey. A cross-sectional design was employed. In Phase 1, a team of experts in survey development produced a draft survey. In Phase 2, the content validity of the draft survey was evaluated by a panel of individuals with expertise in physical activity coalitions. In Phase 3, the survey was administered to 120 individuals on local-, state-, and national-level physical activity coalitions. Responses were subjected to an exploratory factor analysis in order to determine the survey's underlying factor structure, reliability, and validity. Phases 1 and 2yielded a survey instrument with demonstrated content validity. Phase 3 yielded a three-factor model with three subscales: Strategic Alignment, Organizational Alignment, and Providing Input. Each subscale demonstrated high internal consistency reliability and construct validity. The survey instrument developed here demonstrated sound psychometric properties and provides new insight into organizational member involvement in physical activity coalitions. This instrument may be an important tool in developing a more complete picture of coalition functioning in physical activity coalitions specifically and health-based coalitions overall. © 2014 Society for Public Health Education.

  20. Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies

    PubMed Central

    Chawla, Anita J; Mytelka, Daniel S; McBride, Stephan D; Nellesen, Dave; Elkins, Benjamin R; Ball, Daniel E; Kalsekar, Anupama; Towse, Adrian; Garrison, Louis P

    2014-01-01

    Purpose To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. Methods We applied the incremental net health benefit (INHB) framework to quantify the benefits and risks of investigational diabetes drugs using a common survival metric (life-years [LYs]). We constructed a decision analytic model for clinical program development consistent with the requirements of each guidance and simulated diabetes drugs, some of which had elevated CV risk. Assuming constant research budgets, we estimate the impact of increased trial size on drugs investigated. We aggregate treatment benefit and CV risks for each approved drug over a 35-year horizon under each guidance. Results The quantitative analysis suggests that the December 2008 guidance adversely impacts diabetes population health. INHB was −1.80 million LYs, attributable to delayed access to diabetes therapies (−0.18 million LYs) and fewer drugs (−1.64 million LYs), but partially offset by reduced CV risk exposure (0.02 million LYs). Results were robust in sensitivity analyses. Conclusion The health outcomes impact of all potential benefits and risks should be evaluated in a common survival measure, including health gain from avoided adverse events, lost health benefits from delayed or forgone efficacious products, and impact of alternative policy approaches. Quantitative analysis of the December 2008 FDA guidance for diabetes therapies indicates that negative impact on patient health will result. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:24892175

  1. Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies.

    PubMed

    Chawla, Anita J; Mytelka, Daniel S; McBride, Stephan D; Nellesen, Dave; Elkins, Benjamin R; Ball, Daniel E; Kalsekar, Anupama; Towse, Adrian; Garrison, Louis P

    2014-03-01

    To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. We applied the incremental net health benefit (INHB) framework to quantify the benefits and risks of investigational diabetes drugs using a common survival metric (life-years [LYs]). We constructed a decision analytic model for clinical program development consistent with the requirements of each guidance and simulated diabetes drugs, some of which had elevated CV risk. Assuming constant research budgets, we estimate the impact of increased trial size on drugs investigated. We aggregate treatment benefit and CV risks for each approved drug over a 35-year horizon under each guidance. The quantitative analysis suggests that the December 2008 guidance adversely impacts diabetes population health. INHB was -1.80 million LYs, attributable to delayed access to diabetes therapies (-0 .18 million LYs) and fewer drugs (-1.64 million LYs), but partially offset by reduced CV risk exposure (0.02 million LYs). Results were robust in sensitivity analyses. The health outcomes impact of all potential benefits and risks should be evaluated in a common survival measure, including health gain from avoided adverse events, lost health benefits from delayed or for gone efficacious products, and impact of alternative policy approaches. Quantitative analysis of the December 2008 FDA guidance for diabetes therapies indicates that negative impact on patient health will result. Copyright © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

  2. Product safety in Great Britain and the Consumer Protection Act 1987.

    PubMed

    Jenkins, D W; Davies, B T

    1989-09-01

    The Consumer Protection Act 1987 imposes new demands on manufacturers regarding the safety of their products. They can be sued directly by any person injured by their defective goods and prosecuted if they fail to meet the new comprehensive general safety requirement and any other safety provision. Product designers and ergonomists need a sound understanding of and involvement in the legal aspects of product safety. It is now essential to take into account what may reasonably be done with goods, or foreseeable conditions of use, in order to satisfy the test of what is "reasonably safe" and meet the level of safety which "persons generally are entitled to expect" under the law. Any significant progress in product safety will now come through developments in technical standards which will be harmonised throughout the European Community. It is essential that ergonomics considerations be taken into account during the drafting of product specifications if users' interests are to be safeguarded more effectively. Ergonomists will be required to make an even greater contribution in the field of product safety, therefore, by assisting in the determination of the new statutory safety criteria. They are uniquely qualified to ensure that the product user is fully considered at the design and assessment stages which can now be looked upon as an essential pre-requisite of the law and not just sound engineering policy.

  3. Program Impact Evaluations: An Introduction for Managers of Title VII Projects. A Draft Guidebook.

    ERIC Educational Resources Information Center

    Bissell, Joan S.

    Intended to assist administrators in the planning, management, and utilization of evaluation, this guidebook is designed as an introduction and supplement to other evaluation materials for bilingual education programs being developed under federal sponsorship, including evaluation models for Title VII projects. General information is provided on…

  4. Editorial: emerging issues in sociotechnical systems thinking and workplace safety.

    PubMed

    Noy, Y Ian; Hettinger, Lawrence J; Dainoff, Marvin J; Carayon, Pascale; Leveson, Nancy G; Robertson, Michelle M; Courtney, Theodore K

    2015-01-01

    The burden of on-the-job accidents and fatalities and the harm of associated human suffering continue to present an important challenge for safety researchers and practitioners. While significant improvements have been achieved in recent decades, the workplace accident rate remains unacceptably high. This has spurred interest in the development of novel research approaches, with particular interest in the systemic influences of social/organisational and technological factors. In response, the Hopkinton Conference on Sociotechnical Systems and Safety was organised to assess the current state of knowledge in the area and to identify research priorities. Over the course of several months prior to the conference, leading international experts drafted collaborative, state-of-the-art reviews covering various aspects of sociotechnical systems and safety. These papers, presented in this special issue, cover topics ranging from the identification of key concepts and definitions to sociotechnical characteristics of safe and unsafe organisations. This paper provides an overview of the conference and introduces key themes and topics. Sociotechnical approaches to workplace safety are intended to draw practitioners' attention to the critical influence that systemic social/organisational and technological factors exert on safety-relevant outcomes. This paper introduces major themes addressed in the Hopkinton Conference within the context of current workplace safety research and practice challenges.

  5. Editorial: emerging issues in sociotechnical systems thinking and workplace safety

    PubMed Central

    Noy, Y. Ian; Hettinger, Lawrence J.; Dainoff, Marvin J.; Carayon, Pascale; Leveson, Nancy G.; Robertson, Michelle M.; Courtney, Theodore K.

    2015-01-01

    The burden of on-the-job accidents and fatalities and the harm of associated human suffering continue to present an important challenge for safety researchers and practitioners. While significant improvements have been achieved in recent decades, the workplace accident rate remains unacceptably high. This has spurred interest in the development of novel research approaches, with particular interest in the systemic influences of social/organisational and technological factors. In response, the Hopkinton Conference on Sociotechnical Systems and Safety was organised to assess the current state of knowledge in the area and to identify research priorities. Over the course of several months prior to the conference, leading international experts drafted collaborative, state-of-the-art reviews covering various aspects of sociotechnical systems and safety. These papers, presented in this special issue, cover topics ranging from the identification of key concepts and definitions to sociotechnical characteristics of safe and unsafe organisations. This paper provides an overview of the conference and introduces key themes and topics. Practitioner Summary: Sociotechnical approaches to workplace safety are intended to draw practitioners' attention to the critical influence that systemic social/organisational and technological factors exert on safety-relevant outcomes. This paper introduces major themes addressed in the Hopkinton Conference within the context of current workplace safety research and practice challenges. PMID:25819595

  6. Assessment of the Draft AIAA S-119 Flight Dynamic Model Exchange Standard

    NASA Technical Reports Server (NTRS)

    Jackson, E. Bruce; Murri, Daniel G.; Hill, Melissa A.; Jessick, Matthew V.; Penn, John M.; Hasan, David A.; Crues, Edwin Z.; Falck, Robert D.; McCarthy, Thomas G.; Vuong, Nghia; hide

    2011-01-01

    An assessment of a draft AIAA standard for flight dynamics model exchange, ANSI/AIAA S-119-2011, was conducted on behalf of NASA by a team from the NASA Engineering and Safety Center. The assessment included adding the capability of importing standard models into real-time simulation facilities at several NASA Centers as well as into analysis simulation tools. All participants were successful at importing two example models into their respective simulation frameworks by using existing software libraries or by writing new import tools. Deficiencies in the libraries and format documentation were identified and fixed; suggestions for improvements to the standard were provided to the AIAA. An innovative tool to generate C code directly from such a model was developed. Performance of the software libraries compared favorably with compiled code. As a result of this assessment, several NASA Centers can now import standard models directly into their simulations. NASA is considering adopting the now-published S-119 standard as an internal recommended practice.

  7. Editing Tips for Technical Publications in the Joint Nuclear Weapons Publication System (JNWPS)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    ALLEN, TARA S.

    2002-12-01

    These editing tips contain helpful suggestions to assist writers who are writing, editing, and publishing technical publications in the JNWPS. The suggestions clarify some of the most common writing problems and requirements of two publications used in the JNWPS: ''DOE-DTRA TP 1-1, Joint Nuclear Weapons Publications System Operating Procedures, Specifications, and Standards, and United States Government Printing Office Style Manual''. Topics include requirements for abbreviations, formats for drafts, layouts of illustrations and tables, appropriate wording for interim changes, guidance for creating a list of effective pages, how to insert and delete pages and paragraphs, referencing other technical publications, use ofmore » revision bars, requirements for safety precautions, use of hyphens, and how to place warnings, cautions, and notes. Also included are a writer's checklist, samples of draft title pages, and a section of helpful tips for the writers who use the department's desktop publishing software program, Adobe{reg_sign} FrameMaker{reg_sign}.« less

  8. Propulsion Test Handbook: MSFC and SSC. Draft 01

    NASA Technical Reports Server (NTRS)

    Hammond, John M.

    2010-01-01

    This Handbook was prepared to provide Propulsion Test Personnel a central source of fundamental reference material. The Testing Process, which is a three-part process of pre-test activities, testing, and post-test activities, involves a collaborative effort from the mechanical, electrical, safety, and environmental disciplines in the test environment. Pre-test activities, testing, and post-test activities processes will vary, per test requirements; however, the content of this Handbook should cover basic procedures and standards that are shared across Centers.

  9. A Tale of Two Cities: Greensburg Resurrected as a National Model for Green Communities

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Shelley Gonzales

    This fact sheet provides a summary of how NREL's technical assistance in Greensburg, Kansas, helped the town rebuild green after recovering from a tornado in May 2007. To help local distributed system owners get the most value for electricity sent back to the grid, NREL drafted safety and reliability ordinances, an interconnection agreement, and net-metering policies for the city to consider. NREL and the Energy Department also assisted with wind energy resource analysis, feasibility studies, and business plans.

  10. Joint Conference on Marine Safety and Environment/Ship Production (1st), held 1-5 June 1992

    DTIC Science & Technology

    1992-06-05

    have to face fresh challenges in the future. But as long as we regard these challenges as opportunities, we will remain masters of our own destiny ...has recently published for discussion an “ Embryo Code of Practice” (1991) entitled “Engineers and Risk Issues”. Thii draft Code is intended to...Department of Energy5 Her Majesty’s Stationery Office. Cm.1310. The Engineering Counci1 (1991) Engineers and Risk Issues : An Embryo Code of Practice. London

  11. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (2016 Interagency Science Discussion Draft)

    EPA Science Inventory

    In December 2016, EPA finalized its Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide. EPA’s evaluation was reviewed internally by EPA and by other federal agencies and White House Offices in October 2016, before public release. Consistent with the May 2009 IRIS asse...

  12. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

    PubMed

    Fraser, Alan G; Daubert, Jean-Claude; Van de Werf, Frans; Estes, N A Mark; Smith, Sidney C; Krucoff, Mitchell W; Vardas, Panos E; Komajda, Michel

    2011-07-01

    The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

  13. The process of collecting and evaluating evidences for the development of Guidelines for the management of rheumatoid arthritis, Japan College of Rheumatology 2014: Utilization of GRADE approach.

    PubMed

    Kojima, Masayo; Nakayama, Takeo; Kawahito, Yutaka; Kaneko, Yuko; Kishimoto, Mitsumasa; Hirata, Shintaro; Seto, Yohei; Endo, Hirahito; Ito, Hiromu; Kojima, Toshihisa; Nishida, Keiichiro; Matsushita, Isao; Tsutani, Kiichiro; Igarashi, Ataru; Kamatani, Naoyuki; Hasegawa, Mieko; Miyasaka, Nobuyuki; Yamanaka, Hisashi

    2016-01-01

    To describe the process of collecting and evaluating evidence for treating rheumatoid arthritis (RA) for developing clinical practice guidelines (CPGs) for rheumatologists in Japan. The task force comprised rheumatologists, epidemiologists, health economists, and patients. First, the critical outcomes were determined according to a three-round Delphi method, and eight topics with 88 clinical questions (CQs) were formulated. A systematic review of CQs was conducted using the Cochran Database of Systematic Reviews, MEDLINE, and Japana Centra Revvo Medicina (2003-2012). A questionnaire survey and focus group interview were performed to capture the patients' values and preferences. Data from the National Health Insurance drug price list and product information provided by pharmaceutical companies were collected to evaluate drug cost and safety. The GRADE approach was used to describe the evidence quality and determine the strength of recommendations. Recommendations were developed using a modified Delphi method by a multidisciplinary panel including patients. Eight meetings and frequent e-mail communications were conducted to draft a quality assessment of evidence and recommendations. For 88 CQs, recommendation statements were determined. Using the GRADE approach, new CPGs successfully addressed important clinical issues for treating RA patients. Timely updating of recommendations should be routinely considered.

  14. Radiofrequency ablation for hepatic hemangiomas: A consensus from a Chinese panel of experts

    PubMed Central

    Gao, Jun; Fan, Rui-Fang; Yang, Jia-Yin; Cui, Yan; Ji, Jian-Song; Ma, Kuan-Sheng; Li, Xiao-Long; Zhang, Long; Xu, Chong-Liang; Kong, Xin-Liang; Ke, Shan; Ding, Xue-Mei; Wang, Shao-Hong; Yang, Meng-Meng; Song, Jin-Jin; Zhai, Bo; Nin, Chun-Ming; Guo, Shi-Gang; Xin, Zong-Hai; Lu, Jun; Dong, Yong-Hong; Zhu, Hua-Qiang; Sun, Wen-Bing

    2017-01-01

    Recent studies have shown that radiofrequency (RF) ablation therapy is a safe, feasible, and effective procedure for hepatic hemangiomas, even huge hepatic hemangiomas. RF ablation has the following advantages in the treatment of hepatic hemangiomas: minimal invasiveness, definite efficacy, high safety, fast recovery, relatively simple operation, and wide applicability. It is necessary to formulate a widely accepted consensus among the experts in China who have extensive expertise and experience in the treatment of hepatic hemangiomas using RF ablation, which is important to standardize the application of RF ablation for the management of hepatic hemangiomas, regarding the selection of patients with suitable indications to receive RF ablation treatment, the technical details of the techniques, therapeutic effect evaluations, management of complications, etc. A final consensus by a Chinese panel of experts who have the expertise of using RF ablation to treat hepatic hemangiomas was reached by means of literature review, comprehensive discussion, and draft approval. PMID:29093616

  15. The new standard of fluids for hemodialysis in Japan.

    PubMed

    Kawanishi, Hideki; Masakane, Ikuto; Tomo, Tadashi

    2009-01-01

    The standard of fluids for hemodialysis is being evaluated by the International Organization for Standardization (ISO), and will be decided within a few years. In 2008, the Japanese Society for Dialysis Therapy (JSDT) proposed the standard of fluids for hemodialysis by taking the draft ISO standard into consideration and the circumstances in Japan. It was characteristically a standard for Japan, where the central dialysis fluid delivery system (CDDS) is routinely used. In addition, the therapeutic application of each dialysis fluid is clarified. Since high-performance dialyzers are frequently employed in Japan, the standard recommends that ultrapure dialysis fluid be used for all dialysis modalities at all dialysis facilities. It also recommends that the dialysis equipment safety management committee at each facility validate the microbiological qualities of online-prepared substitution fluid, making the responsibility of the dialysis facility clear. This standard is more rigid than those of other countries, and is expected to contribute to improvements in the survival outcome of dialysis patients. (c) 2009 S. Karger AG, Basel.

  16. Consensus Conference Findings on Supragingival and Subgingival Air Polishing.

    PubMed

    Cobb, Charles M; Daubert, Diane M; Davis, Karen; Deming, Jodi; Flemmig, Thomas F; Pattison, Anna; Roulet, Jean-François; Stambaugh, Roger V

    2017-02-01

    A consensus conference was convened to evaluate and address issues of safety and efficacy when using glycine powder in an air-powder jet device for supra- and subgingival applications during dental prophylaxis and periodontal maintenance. The conference reported the following conclusions: 1) Supra- and subgingival air polishing using glycine powder is safe and effective for removal of biofilms from natural tooth structure and restorative materials; 2) there is no evidence of soft-tissue abrasion when using glycine powder in an air-polishing device; 3) in periodontal probing depths of 1 mm to 4 mm, glycine-powder air polishing, using a standard air-polishing nozzle, is more effective at removing subgingival biofilm than manual or ultrasonic instruments; and 4) at probing depths of 5 mm to 9 mm, using a subgingival nozzle, glycine powder air polishing is more effective at removing subgingival biofilm than manual or ultrasonic instrumentation. This conference statement, supported by an industry grant, was drafted by a panel of distinguished dental professionals.

  17. Metropolitan Model Deployment Initiative : San Antonio Evaluation Report : Final Draft

    DOT National Transportation Integrated Search

    2000-05-01

    This report presents the evaluation results of the San Antonio, Texas Metropolitan Model Deployment Initiative (MMDI). The San Antonio MMDI sought to make improvements in six key transportation goals. The first of these goals was the expansion and st...

  18. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms August 21, 1946 to August 22, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1946-01-01

    Tables I and II of this report summarize the gust and draft velocity data for thunderstorm flights 25 and 26 of August 21, 1946 and August 22, 1946, respectively. These dta were evaluated from records of NACA instruments installed in P-61C airplanes and are of the type presented in reference 1 for previous flights. Table III summarizes the readings of a milliammeter which was used in conjunction with other equipment to indicate ambient air temperature during thunderstorm surveys. These data were read from motion-picture records of the instrument and include all cases in which variations in the instrument indications were noted during the present flights.

  19. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes Within Thunderstorms August 14, 1946 to August 15, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1947-01-01

    Tables I and II of the present paper summarize the gust and draft velocity data for thunderstorm-flights 21 and 22 of August 14, 1946 and August 15, 1946, respectively. These data were evaluated from records of NACA airspeed-altitude and acceleration recorders installed in P-61C airplanes and are of the type presented for previous flights. Table III summarizes the readings of a milliammeter which was used in conjunction with other equipment to indicate ambient-air temperature during thunderstorm surveys. These data were read from photo-observer records and include all cases in which variations of the instrument indications were noted for the present flights.

  20. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms. IV - July 19, 1946 to July 20, 1946 at Orlando, Florida. Part 4; July 19, 1946 to July 20, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1946-01-01

    Summaries of the gust and draft velocities evaluated from acceleration and airspeed-altitude records taken by NACA instruments installed n P-61c airplanes participating in thunderstorm flights 12 and 13 of July 19, 1946, and July 20, 1946, respectively, are presented in tables I and II herein. These data are of the type presented in reference 1 for previous flights. Inspection of the motion picture records of the pilots' instrument panels for the present flights indicated that the milliameter connected to equipment for measuring ambient air temperature read zero throughout all traverses.

  1. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms: September 5, 1946 to September 10, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1947-01-01

    Tables I and II of this report summarize the gust and draft velocity data for thunderstorm flights 31, 32, and 33 of September 5, 1946, September 6, 1946, and September 10, 1946, respectively. These data were evaluated from records of NACA instruments installed in P-61C airplanes and are of the type presented for previous flights. Table III summarizes the readings of a milliammeter which was used in conjunction with other equipment to indicate ambient air temperature during thunderstorm surveys. These data were read from motion-picture records of the instrument and include all cases in which variations in the instrument indications were noted for the present flights.

  2. Standards for QUality Improvement Reporting Excellence 2.0: revised publication guidelines from a detailed consensus process.

    PubMed

    Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

    2016-02-01

    Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  3. Home Start Evaluation Study. Interim Report II: Program Analysis. Revised Draft.

    ERIC Educational Resources Information Center

    Deloria, Dennis; And Others

    This document is the second in a series of evaluative reports directed to evaluation needs of Home Start planners and administrators. It focuses on implementation data about programs gathered during local site visits conducted in the spring and fall of 1972. The two basic evaluative questions asked are: (1) What was Home Start intended by its…

  4. CFD based draft tube hydraulic design optimization

    NASA Astrophysics Data System (ADS)

    McNabb, J.; Devals, C.; Kyriacou, S. A.; Murry, N.; Mullins, B. F.

    2014-03-01

    The draft tube design of a hydraulic turbine, particularly in low to medium head applications, plays an important role in determining the efficiency and power characteristics of the overall machine, since an important proportion of the available energy, being in kinetic form leaving the runner, needs to be recovered by the draft tube into static head. For large units, these efficiency and power characteristics can equate to large sums of money when considering the anticipated selling price of the energy produced over the machine's life-cycle. This same draft tube design is also a key factor in determining the overall civil costs of the powerhouse, primarily in excavation and concreting, which can amount to similar orders of magnitude as the price of the energy produced. Therefore, there is a need to find the optimum compromise between these two conflicting requirements. In this paper, an elaborate approach is described for dealing with this optimization problem. First, the draft tube's detailed geometry is defined as a function of a comprehensive set of design parameters (about 20 of which a subset is allowed to vary during the optimization process) and are then used in a non-uniform rational B-spline based geometric modeller to fully define the wetted surfaces geometry. Since the performance of the draft tube is largely governed by 3D viscous effects, such as boundary layer separation from the walls and swirling flow characteristics, which in turn governs the portion of the available kinetic energy which will be converted into pressure, a full 3D meshing and Navier-Stokes analysis is performed for each design. What makes this even more challenging is the fact that the inlet velocity distribution to the draft tube is governed by the runner at each of the various operating conditions that are of interest for the exploitation of the powerhouse. In order to determine these inlet conditions, a combined steady-state runner and an initial draft tube analysis, using a stage interface between them, must first be performed for each operating condition. Due to the computationally intensive nature of the evaluation process, the efficiency of the optimization algorithm becomes important. Therefore, a state-of-the-art hierarchical-metamodel-assisted evolutionary algorithm is used.

  5. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms: August 23, 1946 to September 4, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1946-01-01

    This report presents the results obtained from gust and draft velocity measurements within thunderstorms for the period August 23, 1946 to September 4, 1946 at Orlando, Florida. These data are summarized in tables I end II and are of the type presented in reference 1 for previous flights. In several of the surveys, indications of ambient air temperature were obtained from photo-observer records. These data are summarized in table III.

  6. Evaluation of Gust and Draft Velocities from Flights of P-61C Airplanes within Thunderstorms July 22, 1946 to July 23, 1946 at Orlando, Florida

    NASA Technical Reports Server (NTRS)

    Tolefson, H. B.

    1947-01-01

    The results obtained from measurements of gust and draft velocities within thunderstorms for the period July 22, 1946 to July 23, 1946 at Orlando, Florida, are presented herein. These data are summarized in tables I and II, respectively, and are of the type presented in reference 1 for previous flights. Inspection of photo-observer records for the flights indicated that no data on ambient air temperature variations within thunderstorms were obtained.

  7. Draft Plan to Develop Non-Intrusive Load Monitoring Test Protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mayhorn, Ebony T.; Sullivan, Greg P.; Petersen, Joseph M.

    2015-09-29

    This document presents a Draft Plan proposed to develop a common test protocol that can be used to evaluate the performance requirements of Non-Intrusive Load Monitoring. Development on the test protocol will be focused on providing a consistent method that can be used to quantify and compare the performance characteristics of NILM products. Elements of the protocols include specifications for appliances to be used, metrics, instrumentation, and a procedure to simulate appliance behavior during tests. In addition, three priority use cases for NILM will be identified and their performance requirements will specified.

  8. Integrated Science Assessment (ISA) for Sulfur Oxides ...

    EPA Pesticide Factsheets

    EPA has announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Sulfur Oxides – Health Criteria has been made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation of the most policy-relevant science and will ultimately provide the scientific bases for EPA’s decision regarding whether the current standard for SO2 sufficiently protects public health. Sulfur oxides is one of six principal (or “criteria”) pollutants for which EPA has established national ambient air quality standards (NAAQS).

  9. Integrated Science Assessment (ISA) for Sulfur Oxides ...

    EPA Pesticide Factsheets

    EPA has announced that the First External Review Draft of the Integrated Science Assessment (ISA) for Sulfur Oxides – Health Criteria has been made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation of the most policy-relevant science and will ultimately provide the scientific bases for EPA’s decision regarding whether the current standard for SO2 sufficiently protects public health. Sulfur oxides is one of six principal (or “criteria”) pollutants for which EPA has established national ambient air quality standards (NAAQS).

  10. Knowledge-based systems in Japan

    NASA Technical Reports Server (NTRS)

    Feigenbaum, Edward; Engelmore, Robert S.; Friedland, Peter E.; Johnson, Bruce B.; Nii, H. Penny; Schorr, Herbert; Shrobe, Howard

    1994-01-01

    This report summarizes a study of the state-of-the-art in knowledge-based systems technology in Japan, organized by the Japanese Technology Evaluation Center (JTEC) under the sponsorship of the National Science Foundation and the Advanced Research Projects Agency. The panel visited 19 Japanese sites in March 1992. Based on these site visits plus other interactions with Japanese organizations, both before and after the site visits, the panel prepared a draft final report. JTEC sent the draft to the host organizations for their review. The final report was published in May 1993.

  11. Autism spectrum disorders according to DSM-IV-TR and comparison with DSM-5 draft criteria: an epidemiological study.

    PubMed

    Mattila, Marja-Leena; Kielinen, Marko; Linna, Sirkka-Liisa; Jussila, Katja; Ebeling, Hanna; Bloigu, Risto; Joseph, Robert M; Moilanen, Irma

    2011-06-01

    The latest definitions of autism spectrum disorders (ASDs) were specified in DSM-IV-TR in 2000. DSM-5 criteria are planned for 2013. Here, we estimated the prevalence of ASDs and autism according to DSM-IV-TR, clarified confusion concerning diagnostic criteria, and evaluated DSM-5 draft criteria for ASD posted by the American Psychiatry Association (APA) in February 2010. This was an epidemiological study of 5,484 eight-year-old children in Finland, 4,422 (81%) of them rated via the Autism Spectrum Screening Questionnaire by parents and/or teachers, and 110 examined by using a structured interview, semi-structured observation, IQ measurement, school-day observation, and patient records. Diagnoses were assigned according to DSM-IV-TR criteria and DSM-5 draft criteria in children with a full-scale IQ (FSIQ) ≥50. Patient records were evaluated in children with an FSIQ <50 to discover diagnoses of ASDs. The prevalence of ASDs was 8.4 in 1,000 and that of autism 4.1 in 1,000 according to DSM-IV-TR. Of the subjects with ASDs and autism, 65% and 61% were high-functioning (FSIQ ≥70), respectively. The prevalence of pervasive developmental disorder not otherwise specified was not estimated because of inconsistency in DSM-IV-TR criteria. DSM-5 draft criteria were shown to be less sensitive in regard to identification of subjects with ASDs, particularly those with Asperger's syndrome and some high-functioning subjects with autism. DSM-IV-TR helps with the definition of ASDs only up to a point. We suggest modifications to five details of DSM-5 draft criteria posted by the APA in February 2010. Completing revision of DSM criteria for ASDs is a challenging task. Copyright © 2011 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  12. 78 FR 15955 - Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22...

  13. Analysis, modeling, and simulation (AMS) testbed development and evaluation to support dynamic mobility applications (DMA) and active transportation and demand management (ATDM) programs - evaluation plan : draft report.

    DOT National Transportation Integrated Search

    2016-07-13

    The primary objective of this project is to develop multiple simulation Testbeds/transportation models to evaluate the impacts of DMA connected vehicle applications and the active and dynamic transportation management (ATDM) strategies. The outputs (...

  14. 77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver... Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm...

  15. 78 FR 49782 - Interim Staff Guidance on Changes During Construction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-15

    ... seven comments on the Draft ISG from the Nuclear Energy Institute (NEI) (ADAMS Accession No. ML12089A019... construction impacts evaluation and the 10 CFR 50.59- like review (including applicability determination..., the construction impacts evaluation and the 10 CFR 50.59 and 10 CFR 50-59-like evaluation (including...

  16. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... Evaluation and Research- Regulated Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm... Drug Evaluation and Research (HFD-003), Food and Drug Administration, Bldg. 51, Rm. 4154, 10903 New...

  17. IRIS Toxicological Review of Ammonia (Interagency Science ...

    EPA Pesticide Factsheets

    On June 1, 2012, the draft Toxicological Review of Ammonia and the draft charge to external peer reviewers were released for external peer review and public comment. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White House Offices before public release. Consistent with the May 2009 IRIS assessment development process, all written comments on IRIS assessments submitted by other federal agencies and White House Offices are made publicly available. Accordingly, interagency comments and the interagency science consultation materials provided to other agencies, including interagency review drafts of the IRIS Toxicological Review of Ammonia and the charge to external peer reviewers, are posted on this site. EPA is undertaking an Integrated Risk Information System (IRIS) health assessment for ammonia. IRIS is an EPA database containing Agency scientific positions on potential adverse human health effects that may result from chronic (or lifetime) exposure to chemicals in the environment. IRIS contains chemical-specific summaries of qualitative and quantitative health information in support of two steps of the risk assessment paradigm, i.e., hazard identification and dose-response evaluation. IRIS assessments are used in combination with specific situational exposure assessment information to evaluate potential public health risk associated with environmental contaminants.

  18. Performance Evaluation of a Mechanical Draft Cross Flow Cooling Towers Employed in a Subtropical Region

    NASA Astrophysics Data System (ADS)

    Muthukumar, Palanisamy; Naik, Bukke Kiran; Goswami, Amarendra

    2018-02-01

    Mechanical draft cross flow cooling towers are generally used in a large-scale water cooled condenser based air-conditioning plants for removing heat from warm water which comes out from the condensing unit. During this process considerable amount of water in the form of drift (droplets) and evaporation is carried away along with the circulated air. In this paper, the performance evaluation of a standard cross flow induced draft cooling tower in terms of water loss, range, approach and cooling tower efficiency are presented. Extensive experimental studies have been carried out in three cooling towers employed in a water cooled condenser based 1200 TR A/C plant over a period of time. Daily variation of average water loss and cooling tower performance parameters have been reported for some selected days. The reported average water loss from three cooling towers is 4080 l/h and the estimated average water loss per TR per h is about 3.1 l at an average relative humidity (RH) of 83%. The water loss during peak hours (2 pm) is about 3.4 l/h-TR corresponding to 88% of RH and the corresponding efficiency of cooling towers varied between 25% and 45%.

  19. Evolution of a policy disallowing the use of alternative therapies in a health system.

    PubMed

    Walker, P C

    2000-11-01

    The evolution of a policy disallowing patients' use of alternative therapies in a health system is described. The pharmacy and therapeutics (P&T) committee at Children's Hospital of Michigan, a part of the Detroit Medical Center (DMC), was asked to review the appropriateness of allowing inpatients to bring in and use alternative therapy products during their hospitalization. Recognizing the interest of consumers in alternative medicines and patients' growing involvement in their own care, the committee drafted a policy that allowed patients to continue taking dietary supplements after being admitted to the hospital. If the physician had no concerns about potential toxicities or drug interactions for a particular product, he or she would write a medication order allowing it to be used. Purchasing and administering the products were deemed the responsibility of the patient or the family. However, many issues concerning supplements remained unresolved, including questions about safety, efficacy, dosing, drug interactions, ethical conflicts, and liability. Ultimately, the P&T committee decided that the potential risks associated with alternative therapies outweighed potential benefits and adopted a policy disallowing the use of alternative therapies by hospitalized patients. The policy was eventually implemented at all eight DMC hospitals. A health system responded to patients' desire to continue their use of alternative therapies during hospitalization by drafting a policy allowing such use. However, concerns related to safety, efficacy, ethics, and liability led to the abandonment of the liberal policy and implementation of a highly restrictive one.

  20. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  1. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 7 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  2. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 3 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  3. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  4. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  5. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 7 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  6. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  7. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 7 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  8. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 3 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  9. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 3 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  10. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 3 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  11. 46 CFR 97.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  12. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  13. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 3 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...

  14. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 7 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  15. Relationship between the Placental Retention Time and the Reproductive Performance at the Foal Heat in Thoroughbred and a Comparison with Heavy Draft

    PubMed Central

    ISHII, Mitsuo; AOKI, Takahiro; YAMAKAWA, Kazuhiro; MAGATA, Fumie; GOJO, Chikara; ITO, Katsumi; KAYANO, Mitsunori; NAMBO, Yasuo

    2013-01-01

    The aim of this study was to clarify the relationship between the placental retention time (PRT) and the reproductive performance following mating at the foal heat in Thoroughbreds. For this purpose, we interviewed 292 farmers over a period of 3 years with questionnaires evaluating foaling, expulsion of placenta and reproductive performance at the foal heat in 1,432 mares. The obtained data were later compared with a previous study of heavy draft mares. The average of the PRT of the 1,432 Thoroughbred mares was 58 ± 88 min (mean ± SD). The mean PRT of Thoroughbreds was significantly shorter than that of the148 min of heavy draft mares. The incidences of retained placenta (RP) occurring in the Thoroughbred mares were 5.2 and 4.0%, for over 3 and 4 hr after foaling, respectively. The incidence of RP over 4 hr was significantly lower than that of 25% in heavy draft mares. The pregnancy rate at foal heat of the mares in which PRT was less than 3 hr was 37%, and it significantly decreased to 11% for those with PRT of more than 3 hr. In the comparison of the reproductive performance between Thoroughbred and heavy draft mares, the pregnancy rate of Thoroughbreds dropped drastically to 10% when PRT exceeded 40, and in consequence, the pregnancy rate of Thoroughbreds was significantly lower than the 30% of heavy draft mares, which had a PRT of over 4 hr. In conclusion, the Thoroughbred mares had a low incidence of RP, however, a PRT exceeding 3 hr severely affected the reproductive performance at the foal heat. PMID:24833998

  16. Relationship between the Placental Retention Time and the Reproductive Performance at the Foal Heat in Thoroughbred and a Comparison with Heavy Draft.

    PubMed

    Ishii, Mitsuo; Aoki, Takahiro; Yamakawa, Kazuhiro; Magata, Fumie; Gojo, Chikara; Ito, Katsumi; Kayano, Mitsunori; Nambo, Yasuo

    2013-01-01

    The aim of this study was to clarify the relationship between the placental retention time (PRT) and the reproductive performance following mating at the foal heat in Thoroughbreds. For this purpose, we interviewed 292 farmers over a period of 3 years with questionnaires evaluating foaling, expulsion of placenta and reproductive performance at the foal heat in 1,432 mares. The obtained data were later compared with a previous study of heavy draft mares. The average of the PRT of the 1,432 Thoroughbred mares was 58 ± 88 min (mean ± SD). The mean PRT of Thoroughbreds was significantly shorter than that of the148 min of heavy draft mares. The incidences of retained placenta (RP) occurring in the Thoroughbred mares were 5.2 and 4.0%, for over 3 and 4 hr after foaling, respectively. The incidence of RP over 4 hr was significantly lower than that of 25% in heavy draft mares. The pregnancy rate at foal heat of the mares in which PRT was less than 3 hr was 37%, and it significantly decreased to 11% for those with PRT of more than 3 hr. In the comparison of the reproductive performance between Thoroughbred and heavy draft mares, the pregnancy rate of Thoroughbreds dropped drastically to 10% when PRT exceeded 40, and in consequence, the pregnancy rate of Thoroughbreds was significantly lower than the 30% of heavy draft mares, which had a PRT of over 4 hr. In conclusion, the Thoroughbred mares had a low incidence of RP, however, a PRT exceeding 3 hr severely affected the reproductive performance at the foal heat.

  17. Predictive Validity of National Basketball Association Draft Combine on Future Performance.

    PubMed

    Teramoto, Masaru; Cross, Chad L; Rieger, Randall H; Maak, Travis G; Willick, Stuart E

    2018-02-01

    Teramoto, M, Cross, CL, Rieger, RH, Maak, TG, and Willick, SE. Predictive validity of national basketball association draft combine on future performance. J Strength Cond Res 32(2): 396-408, 2018-The National Basketball Association (NBA) Draft Combine is an annual event where prospective players are evaluated in terms of their athletic abilities and basketball skills. Data collected at the Combine should help NBA teams select right the players for the upcoming NBA draft; however, its value for predicting future performance of players has not been examined. This study investigated predictive validity of the NBA Draft Combine on future performance of basketball players. We performed a principal component analysis (PCA) on the 2010-2015 Combine data to reduce correlated variables (N = 234), a correlation analysis on the Combine data and future on-court performance to examine relationships (maximum pairwise N = 217), and a robust principal component regression (PCR) analysis to predict first-year and 3-year on-court performance from the Combine measures (N = 148 and 127, respectively). Three components were identified within the Combine data through PCA (= Combine subscales): length-size, power-quickness, and upper-body strength. As per the correlation analysis, the individual Combine items for anthropometrics, including height without shoes, standing reach, weight, wingspan, and hand length, as well as the Combine subscale of length-size, had positive, medium-to-large-sized correlations (r = 0.313-0.545) with defensive performance quantified by Defensive Box Plus/Minus. The robust PCR analysis showed that the Combine subscale of length-size was a predictor most significantly associated with future on-court performance (p ≤ 0.05), including Win Shares, Box Plus/Minus, and Value Over Replacement Player, followed by upper-body strength. In conclusion, the NBA Draft Combine has value for predicting future performance of players.

  18. Electronic intermodal supply chain manifest field operational test evaluation draft final report

    DOT National Transportation Integrated Search

    2002-12-01

    This report presents the results of a 2.5 year freight ITS evaluation of an air cargo security and logistics system which was deployed at OHare and JFK international airports. In September 1999, the Federal Highway Administration (FHWA) and the Fe...

  19. A retrospective review of required projects in systems-based practice in a single anesthesiology residency: a 10-year experience.

    PubMed

    Sakai, Tetsuro; Emerick, Trent D; Patel, Rita M

    2015-09-01

    The Accreditation Council for Graduate Medical Education has emphasized in its core competencies and more recently, in its Milestones Project, that residents understand the importance of systems-based practice (SBP). The objectives of the study are to evaluate the quality of residents' SBP projects and to determine the degrees that were subsequently implemented. A retrospective educational observational study. A university-based anesthesiology training institution. One hundred forty-nine anesthesiology residents in their final (postgraduate year 4) year of training who completed SBP projects for the last 10 years (2004-2013). A structured SBP course was provided for postgraduate year 4 anesthesiology residents with deadlines set such as project identification, data collection, and proposal draft. Each resident's written SBP proposal received inputs by 2 members of the department executive steering committee. The SBP projects concluded with oral presentations by each resident to the department executive steering committee, who provided overall scores. All SBP projects were categorized into 7 categories: safety initiatives, economic analysis, process analysis, policy change recommendations, education initiatives, teamwork/communication, and operating room efficiency. Evaluation scores using a Likert scale (1-9, where 9 is the best) were analyzed. The rate of implementation of project ideas within the department based on the presentations to the executive committee was examined. Of 149 projects, policy change recommendations was the most frequently chosen category (46 projects; 30.9%), followed by process analysis (36 projects; 24.2%). The overall evaluation score was 7.6 ± 0.6 (mean ± SD). A total of 53 projects (35.6%) were implemented in the department. There was no statistical difference between SBPs with implementation vs SBPs without implementation in terms of evaluation scores, year of the presentation, or categories. This SBP project has given residents the opportunity to participate in a hospital system change aiming to improve efficiency and safety. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 1 2014-10-01 2014-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  1. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 1 2011-10-01 2011-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  2. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  3. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 1 2013-10-01 2013-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  4. 46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 1 2012-10-01 2012-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...

  5. Values, Valuing, and Evaluation. Research on Evaluation Program, Paper and Report Series. Interim Draft.

    ERIC Educational Resources Information Center

    Gephart, William J.

    The paper discusses the meaning of value and valuing, their roles in evaluation, and the potency of value systems in problem solving logic. Evaluation is defined as a process for facilitating decision making. A decision making situation occurs when there are options which are impossible to treat equivalently, and there is an impact in the…

  6. Evaluating the Longevity and Hydraulic Performance of Permeable Reactive Barriers at Department of Defense Sites

    DTIC Science & Technology

    2001-10-01

    Draft Final Report Evaluating the Longevity and Hydraulic Performance of Permeable Reactive Barriers at Department of Defense Sites Prepared for...AND SUBTITLE Evaluating the Longevity and Hydraulic Performance of Permeable Reactive Barriers at Department of Defense Sites 5a. CONTRACT NUMBER...34 4.3.2 Hydraulic Performance Evaluation .................................................................... 38 4.3.2.1 Water-Level

  7. Tiger Team Assessment of the Fermi National Accelerator Laboratory

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-06-01

    This draft report documents the Tiger Team Assessment of the Fermi National Accelerator Laboratory (Fermilab) located in Batavia, Illinois. Fermilab is a program-dedicated national laboratory managed by the Universities Research Association, Inc. (URA) for the US Department of Energy (DOE). The Tiger Team Assessment was conducted from May 11 to June 8, 1992, under the auspices of DOE's Office of Special Projects (OSP) under the Office of the Assistant Secretary for Environment, Safety and Health (EH). The assessment was comprehensive, encompassing environmental, safety and health (ES H), and quality assurance (QA) disciplines; site remediation; facilities management; and waste management operations.more » Compliance with applicable Federal , State of Illinois, and local regulations; applicable DOE Orders; best management practices; and internal Fermilab requirements was addressed. In addition, an evaluation of the effectiveness of DOE and Fermilab management of the ES H/QA and self-assessment programs was conducted. The Fermilab Tiger Team Assessment is part a larger, comprehensive DOE Tiger Team Independent Assessment Program planned for DOE facilities. The objective of the initiative is to provide the Secretary of Energy with information on the compliance status of DOE facilities with regard to ES H requirements, root causes for noncompliance, adequacy of DOE and contractor ES H management programs, response actions to address the identified problem areas, and DOE-wide ES H compliance trends and root causes.« less

  8. Tiger Team Assessment of the Fermi National Accelerator Laboratory

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-06-01

    This draft report documents the Tiger Team Assessment of the Fermi National Accelerator Laboratory (Fermilab) located in Batavia, Illinois. Fermilab is a program-dedicated national laboratory managed by the Universities Research Association, Inc. (URA) for the US Department of Energy (DOE). The Tiger Team Assessment was conducted from May 11 to June 8, 1992, under the auspices of DOE`s Office of Special Projects (OSP) under the Office of the Assistant Secretary for Environment, Safety and Health (EH). The assessment was comprehensive, encompassing environmental, safety and health (ES&H), and quality assurance (QA) disciplines; site remediation; facilities management; and waste management operations. Compliancemore » with applicable Federal , State of Illinois, and local regulations; applicable DOE Orders; best management practices; and internal Fermilab requirements was addressed. In addition, an evaluation of the effectiveness of DOE and Fermilab management of the ES&H/QA and self-assessment programs was conducted. The Fermilab Tiger Team Assessment is part a larger, comprehensive DOE Tiger Team Independent Assessment Program planned for DOE facilities. The objective of the initiative is to provide the Secretary of Energy with information on the compliance status of DOE facilities with regard to ES&H requirements, root causes for noncompliance, adequacy of DOE and contractor ES&H management programs, response actions to address the identified problem areas, and DOE-wide ES&H compliance trends and root causes.« less

  9. A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food: Workshop Proceedings.

    PubMed

    Hanlon, Paul; Brorby, Gregory P; Krishan, Mansi

    2016-05-01

    Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessing the need for and benefit of mitigation of process-formed compounds, including criteria to objectively assess the impact of mitigation as well as research needed to support this process. Workshop participants provided real-time feedback on a draft framework in the form of a decision tree developed by the ILSI North America Technical Committee on Food and Chemical Safety to a panel of experts, and they discussed the importance of communicating the value of such a process to the larger scientific community and, ultimately, the public. The outcome of the workshop was a decision tree that can be used by the scientific community and could form the basis of a global approach to assessing the risks associated with mitigation of process-formed compounds. © The Author(s) 2016.

  10. A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food

    PubMed Central

    Brorby, Gregory P.; Krishan, Mansi

    2016-01-01

    Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessing the need for and benefit of mitigation of process-formed compounds, including criteria to objectively assess the impact of mitigation as well as research needed to support this process. Workshop participants provided real-time feedback on a draft framework in the form of a decision tree developed by the ILSI North America Technical Committee on Food and Chemical Safety to a panel of experts, and they discussed the importance of communicating the value of such a process to the larger scientific community and, ultimately, the public. The outcome of the workshop was a decision tree that can be used by the scientific community and could form the basis of a global approach to assessing the risks associated with mitigation of process-formed compounds. PMID:27102178

  11. Locomotive fuel vapor reclamation system field evaluation and cost-benefit analysis : draft final report.

    DOT National Transportation Integrated Search

    2015-10-21

    This report summarizes the results of the work performed to install a diesel vapor reclamation unit (DVRU) on an SD70 MAC : locomotive of BNSF Railways and its performance evaluation during freight railroad service. One complete DVRU with several : s...

  12. Evaluating Ecological Risk to Invertebrate Receptors from PAHs in Sediments at Hazardous Waste Sites (External Review Draft)

    EPA Science Inventory

    In March 2004, ORD's Ecological Risk Assessment Support Center (ERASC) received a request from the Ecological Risk Assessment Forum (ERAF) relating to the evaluation of ecological risk to vertebrate and benthic invertebrate receptors from polycyclic aromatic hydrocarbon compounds...

  13. Apples, Bloom, and Creativity: The ABC's of Reading Alphabet Books.

    ERIC Educational Resources Information Center

    Taylor, Mary Agnes

    Benjamin Bloom's taxonomy of educational objectives (knowledge, comprehension, application, analysis, synthesis, and evaluation) combined with commonly accepted steps of the creative process (gathering material, reflection, inspiration, first draft or model, and evaluation) can be used to explore some of the possibilities of working with alphabet…

  14. Functional Drafting, Drafting--Intermediate: 9255.02.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course consists of six instructional blocks totaling 135 clock hours: (1) functional drafting, (2) threads and fasteners, (3) pictorial drawings, (4) introduction to electronic drafting, (5) introduction to piping drafting, and (6) Quinmester posttest. Mastery of skills indicated in Drafting-Basic--9255.01 is a prerequisite. In the functional…

  15. 76 FR 41808 - Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ...] Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric Delivery..., announce the availability of the draft environmental impact statement and the draft Oncor Electric Delivery... Oncor Electric Delivery Company, LLC (Applicant; Oncor), and (2) That the Applicant has developed a...

  16. [Contributions of the Council of Europe's Blood Transfusion Steering Committee to the determination of rules for the selection of donors of blood and blood components and the study of sexual behaviors having an impact on blood safety].

    PubMed

    Behr-Gross, M-E; Heiden, M; Norda, R

    2013-05-01

    In November 2009, the Council of Europe's Blood Transfusion Steering Committee created a group of experts to explore the problem of behaviors having an impact on the management of donors of blood and blood components and on blood transfusion safety in Europe. This ad hoc group sought a harmonised interpretation of temporary exclusion (or temporary deferral), as opposed to permanent exclusion (or permanent deferral), in the context of the selection of donors of blood and blood components. It was also given the mandate to assess, on the basis of available data, the possibility of differentiating "at risk" behaviours from behaviours "at high risk" of contamination by serious infectious diseases transmitted by blood, blood components or derived therapeutic products. The primary objective of this work was to ensure the safety of blood, blood components and derived therapeutic products for future recipients by promoting a risk analysis-based approach, given that some countries envisaged amending their provisions for donor selection. However, a risk analysis can only be performed on groups, not individuals, which may give the impression of a discriminatory approach, so it needed to be justified in the context of transfusion safety. A collaborative project, which included an investigation phase, led to the drafting of a technical memorandum that summarised the data collected in ten Council of Europe member states on the selection criteria for blood donors and the epidemiology of infectious diseases (with a focus on human immunodeficiency virus) in the general population and among blood donors. The technical memorandum was published in 2011 on the European Directorate for the Quality of Medicines and Healthcare website dedicated to this project. A draft resolution of the Committee of Ministers of the Council of Europe was then developed by the Council of Europe's Blood Transfusion Steering Committee. This text was circulated among member and observer states of the Council of Europe for review and comments. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  17. [Identification of sentinel events in primary care].

    PubMed

    Olivera Cañadas, G; Cañada Dorado, A; Drake Canela, M; Fernández-Martínez, B; Ordóñez León, G; Cimas Ballesteros, M

    To identify and describe a list of sentinel events (SEs) for Primary Care (PC). A structured experts' consensus was obtained by using two online questionnaires. The participants were selected because of their expertise in PC and patient safety. The first questionnaire assessed the suitability of the hospital SEs established in the National Quality Forum 2006 for use in PC via responses of "yes", "no", or "yes but with modification". In the latter case, a re-wording of the SE was requested. Additionally, inclusion of new SEs was also allowed. The second questionnaire included those SEs with positive responses ("yes", "yes with modification"), so that the experts could choose between the original and alternative drafts, and evaluate the newly described SEs. The questionnaires were completed by 44 out of a total of the 47 experts asked to participate, and a total of 17 SEs were identified as suitable for PC. For the first questionnaire, 12 of the 28 hospital SEs were considered adaptable to PC, of which 11 were re-drafts. Thirty-seven experts proposed new SEs. These mainly concerned problems with medication and vaccines, delay, or lack of assistance, diagnostic delays, and problems with diagnostic tests, and were finally summarised in 5 SEs. In the second questionnaire, ≥65% of the experts chose the alternative wording against the original cases for the 11 SEs suitable for PC. The 5 newly included SEs were considered adequate with a positive response of 70-85%. Having a list of SEs available in PC will help to improve the management of health care risks. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Iterative Design and Classroom Evaluation of Automated Formative Feedback for Improving Peer Feedback Localization

    ERIC Educational Resources Information Center

    Nguyen, Huy; Xiong, Wenting; Litman, Diane

    2017-01-01

    A peer-review system that automatically evaluates and provides formative feedback on free-text feedback comments of students was iteratively designed and evaluated in college and high-school classrooms. Classroom assignments required students to write paper drafts and submit them to a peer-review system. When student peers later submitted feedback…

  19. Analysis, Modeling, and Simulation (AMS) Testbed Development and Evaluation to Support Dynamic Mobility Applications (DMA) and Active Transportation and Demand Management (ATDM) Programs : Evaluation Report for the San Diego Testbed : Draft Report.

    DOT National Transportation Integrated Search

    2017-07-01

    The primary objective of this project is to develop multiple simulation testbeds and transportation models to evaluate the impacts of Connected Vehicle Dynamic Mobility Applications (DMA) and Active Transportation and Demand Management (ATDM) strateg...

  20. 78 FR 2676 - Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... Evaluation and Research (HFD-170), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3160... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0045...

  1. A Computer Model of Drafting Effects on Collective Behavior in Elite 10,000-m Runners.

    PubMed

    Trenchard, Hugh; Renfree, Andrew; Peters, Derek M

    2017-03-01

    Drafting in cycling influences collective behavior of pelotons. Although evidence for collective behavior in competitive running events exists, it is not clear if this results from energetic savings conferred by drafting. This study modeled the effects of drafting on behavior in elite 10,000-m runners. Using performance data from a men's elite 10,000-m track running event, computer simulations were constructed using Netlogo 5.1 to test the effects of 3 different drafting quantities on collective behavior: no drafting, drafting to 3 m behind with up to ~8% energy savings (a realistic running draft), and drafting up to 3 m behind with up to 38% energy savings (a realistic cycling draft). Three measures of collective behavior were analyzed in each condition: mean speed, mean group stretch (distance between first- and last-placed runner), and runner-convergence ratio (RCR), which represents the degree of drafting benefit obtained by the follower in a pair of coupled runners. Mean speeds were 6.32 ± 0.28, 5.57 ± 0.18, and 5.51 ± 0.13 m/s in the cycling-draft, runner-draft, and no-draft conditions, respectively (all P < .001). RCR was lower in the cycling-draft condition but did not differ between the other 2. Mean stretch did not differ between conditions. Collective behaviors observed in running events cannot be fully explained through energetic savings conferred by realistic drafting benefits. They may therefore result from other, possibly psychological, processes. The benefits or otherwise of engaging in such behavior are as yet unclear.

  2. EVALUATION OF ENGINEERING CONTROLS FOR THE MIXING OF FLAVORINGS CONTAINING DIACETYL AND OTHER VOLATILE INGREDIENTS

    PubMed Central

    Hirst, Deborah V.L.; Dunn, Kevin H.; Shulman, Stanley A.; Hammond, Duane R.; Sestito, Nicholas

    2015-01-01

    Exposures to diacetyl, a primary ingredient of butter flavoring, have been shown to cause respiratory disease among workers who mix flavorings. This study focused on evaluating ventilation controls designed to reduce emissions from the flavor mixing tanks, the major source of diacetyl in the plants. Five exhaust hood configurations were evaluated in the laboratory: standard hinged lid-opened, standard hinged lid-closed, hinged lid-slotted, dome with 38-mm gap, and dome with 114-mm gap. Tracer gas tests were performed to evaluate quantitative capture efficiency for each hood. A perforated copper coil was used to simulate an area source within the 1.2-meter diameter mixing tank. Capture efficiencies were measured at four hood exhaust flow rates (2.83, 5.66, 11.3, and 17.0 cubic meters per minute) and three cross draft velocities (0, 30, and 60 meters per minute). All hoods evaluated performed well with capture efficiencies above 90% for most combinations of exhaust volume and cross drafts. The standard hinged lid was the least expensive to manufacture and had the best average capture efficiency (over 99%) in the closed configuration for all exhaust flow rates and cross drafts. The hinged lid-slotted hood had some of the lowest capture efficiencies at the low exhaust flow rates compared to the other hood designs. The standard hinged lid performed well, even in the open position, and it provided a flexible approach to controlling emissions from mixing tanks. The dome hood gave results comparable to the standard hinged lid but it is more expensive to manufacture. The results of the study indicate that emissions from mixing tanks used in the production of flavorings can be controlled using simple inexpensive exhaust hoods. PMID:24649880

  3. Draft Final Decision Document for the North Boundary System Improvements Interim Response Action at the Rocky Mountain Arsenal

    DTIC Science & Technology

    1989-04-01

    and Safety Plan has been developed for the prevention of occupational injuries and illnesses during field activities at RMA. This plan addresses...totaltriThelomethanes radmiutm CD 10(1) 5 .13)* 10(4 Larbon tetrachloride CCL4 0(3)5.4 ’tordane CDN0.004(l) 0.00046(5) CLI3oride CL 250,000(l...numerous carcinogenicity tests in a variety of animals indicate that dieldrin promotes only liver tumors and the tumors develop only in mice. On the basis of

  4. Study of application of ERTS-A imagery to fracture-related mine safety hazards in the coal mining industry

    NASA Technical Reports Server (NTRS)

    Wier, C. E.; Wobber, F. J. (Principal Investigator); Russell, O. R.; Amato, R. V.; Leshendok, T. V.

    1974-01-01

    The author has identified the following significant results. The mine refuse inventory maps were prepared in response to a need by both the State and the coal industry. The lack of information on the scope of the problem handicapped all people concerned in drafting realistic legislation for a severance tax on coal production to raise funds for restoration of refuse sites. The inventory was conducted rapidly and economically, and demonstrated the benefits which can be derived through remote sensing methods.

  5. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  6. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  7. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 3 2012-07-01 2012-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...

  8. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  9. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  10. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...

  11. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...

  12. 76 FR 57760 - Notice of Availability of Draft Resource Management Plan and Draft Environmental Impact Statement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Colorado River... prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for the... alternative) seeks to allocate limited resources among competing human interests, land uses, and conservation...

  13. 33 CFR 401.29 - Maximum draft.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...

  14. 76 FR 59732 - Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ...] Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric Delivery... availability of the draft environmental impact statement (DEIS) and the draft Oncor Electric Delivery Company... announced that Oncor Electric Delivery Company, LLC, has applied under section 10(a)(1)(B) of the Endangered...

  15. Reading, readability, and legibility research: implications for notification letters.

    PubMed

    Zimmerman, D E

    1993-01-01

    This article defines communication science and then briefly describes three research areas relevant to worker notifications: (1) receiving of notification messages, (2) reading and understanding of notification messages, and (3) influences or effects of notification messages on workers. Next, the article focuses on the reading and legibility research relevant to worker notifications and then provides 16 guidelines for drafting worker notifications. Finally, the article suggests evaluating draft notifications by using one or more of the following: skilled editorial reviews, readability scoring, Cloze techniques, signal stopping techniques, in-depth personal interviews, focus groups, and usability testing.

  16. The Epidemiology of Lisfranc Injuries at the National Football League Combine and its Impact on an Athlete’s National Football League Career

    PubMed Central

    McHale, Kevin Jude; Vopat, Bryan George; Sanchez, George; Rossy, William H.; Logan, Catherine; Provencher, Matthew T.

    2017-01-01

    Objectives: Lisfranc injuries may have a detrimental effect on athletic performance and an athlete’s career. Understanding the epidemiology of these injuries in collegiate football players and their impact on future performance may assist team physicians in counseling injured athletes and determining optimal treatment. The purposes of this study are to 1) determine the epidemiology of navicular fractures in players participating in the NFL Combine, 2) define positions and demographics that might be at higher risk for sustaining this injury, and 3) evaluate the radiographic healing and eventual impact the injury and radiographic findings has on Lisfranc injuries on NFL draft position and NFL game play compared to matched controls. Methods: All players who sustained a Lisfranc injury prior to Combine evaluation between 2009 and 2015 were evaluated. The prevalence, positions affected, treatment methods, and number of missed collegiate games were recorded. Radiographic outcomes were analyzed via Combine radiograph findings, while NFL performance outcomes were assessed for all Lisfranc injuries (2009-13) compared to matched controls in first two years of play. Results: A total of 41/2162 (1.8%) Combine participants were identified with Lisfranc injuries, of which 26/41 (63.4%) were managed operatively. When compared to players managed nonoperatively, those who underwent surgery were more likely to go undrafted (38.5% vs. 13.3%, p=0.04) and featured a worse NFL draft pick position (155.6 vs. 109, p=0.03). Lisfranc-injured players were noted to have a worse NFL draft position (142 vs. 111.3, p=0.04), NFL career length ≥2 years (62.5% vs. 69.6%, p=0.23) and fewer games played (16.9 vs. 23.3, p=0.001) and started (6.8 vs. 10.5, p=0.08) within the first two years of NFL career versus controls. Radiographs demonstrated 17/41 (41.5%) athletes with residual Lisfranc joint displacement >2mm compared to the contralateral foot. Lisfranc-injured athletes with >2mm residual displacement had lower draft position (111.2 vs. 156.9, p=0.009), and fewer games played (23.3 vs. 14.4, p=0.001) and started (10.5 vs. 3,1, p=0.03) versus matched controls. Moreover, athletes with >2mm residual displacement featured worse outcomes across all assessed NFL variables versus athletes with ≤2mm residual displacement. Conclusion: Lisfranc injuries identified at the NFL Combine have an adverse effect on an NFL athlete’s draft status, draft position and overall play during initial NFL seasons. In particular, residual displacement of the Lisfranc joint has a detrimental impact on the first two seasons of NFL play and may lead to long lasting negative effects on career.

  17. Epidemiology and Outcomes of Lisfranc Injuries Identified at the National Football League Scouting Combine.

    PubMed

    McHale, Kevin J; Vopat, Bryan G; Beaulieu-Jones, Brendin R; Sanchez, George; Whalen, James M; McDonald, Lucas S; DiGiovanni, Christopher W; Theodore, George H; Provencher, Matthew T

    2017-07-01

    Lisfranc injuries are challenging to treat and may have a detrimental effect on athletic performance. (1) Determine the epidemiological characteristics of Lisfranc injuries at the annual National Football League (NFL) Scouting Combine, (2) define player positions at risk for these injuries, and (3) evaluate the impact that these injuries and radiographic findings have on NFL draft position and performance. Cohort study; Level of evidence, 3. All players who sustained a Lisfranc injury prior to Combine evaluation between 2009 and 2015 were evaluated. The epidemiological characteristics, player positions affected, treatment methods, and number of missed collegiate games were recorded. Radiographic outcomes were analyzed via Combine radiograph findings, while NFL performance outcomes were assessed for all Lisfranc injuries (2009-2013) compared with matched controls in the first 2 years of play. A total of 41 of 2162 (1.8%) Combine participants were identified with Lisfranc injuries, of whom 26 of 41 (63.4%) were managed operatively. Players who underwent surgery were more likely to go undrafted compared with players managed nonoperatively (38.5% vs 13.3%, operative vs nonoperative management, respectively; P = .04) and featured a worse NFL draft pick position (155.6 vs 109; P = .03). Lisfranc-injured players when compared with controls were noted to have worse outcomes in terms of NFL draft position (142 vs 111.3, Lisfranc-injured players vs controls, respectively; P = .04), NFL career length 2 years or longer (62.5% vs 69.6%; P = .23), and number of games played (16.9 vs 23.3; P = .001) and started (6.8 vs 10.5; P = .08) within the first 2 years of their NFL career. Radiographs demonstrated that 17 of 41 (41.5%) athletes had residual Lisfranc joint displacement greater than 2 mm compared with the contralateral foot. Lisfranc-injured athletes with greater than 2 mm residual displacement, when compared with matched controls, had worse draft position (156.9 vs 111.2 for Lisfranc-injured players vs controls, respectively; P = .009) and fewer games played (14.4 vs 23.3; P = .001) and started (3.1 vs 10.5; P = .03). Moreover, athletes with greater than 2 mm residual displacement featured worse outcomes across all assessed NFL variables versus athletes with residual displacement of 2 mm or less. Lisfranc injuries identified at the NFL Combine have an adverse effect on an NFL athlete's draft status, draft position, and overall play during initial NFL seasons. In particular, residual displacement of the Lisfranc joint has a detrimental effect on the first 2 seasons of NFL play and may lead to long-lasting negative effects on the athlete's career.

  18. Developing a Mind-Body Exercise Programme for Stressed Children

    ERIC Educational Resources Information Center

    Wang, Claudia; Seo, Dong-Chul; Geib, Roy W

    2017-01-01

    Objective: To describe the process of developing a Health Qigong programme for stressed children using a formative evaluation approach. Methods: A multi-step formative evaluation method was utilised. These steps included (1) identifying programme content and drafting the curriculum, (2) synthesising effective and age-appropriate pedagogies, (3)…

  19. 76 FR 14660 - Public Comment on the Development of Final Guidance for Evaluating the Vapor Intrusion to Indoor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... Groundwater and Soils (Subsurface Vapor Intrusion Guidance) AGENCY: Environmental Protection Agency (EPA... Pathway from Contaminated Groundwater and Soil (Subsurface Vapor Intrusion Guidance). A draft of the... Evaluating Vapor Intrusion to Indoor Air Pathway from Contaminated Groundwater and Soil (Subsurface Vapor...

  20. Evaluating Technical Communication Faculty: Some Empirically-Based Criteria and Guidelines. Draft.

    ERIC Educational Resources Information Center

    Stevenson, Dwight W.

    As technical communication is a young academic discipline, evaluating technical communication faculty for promotion, tenure, and merit purposes requires special awareness and care. To determine reasonable expectations of faculty achievement, a study documented the range, types, and frequency of activities of 12 professors and 12 associate…

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